FDA Product Code
FDA Product Code FPL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5410
510(k) Clearances — 25 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K220742 | NxtGen Infant Transport Incubator | International Biomedical | 2022-07-15 | Traditional | PDF ↗ |
| K161918 | SREE MRI Transport Incubator | Advanced Imaging Research Dba Sree Medical Systems | 2017-03-03 | Traditional | PDF ↗ |
| K141565 | GLOBE-TROTTER GT5400 | Draeger Medical Systems, Inc. | 2014-09-10 | Traditional | PDF ↗ |
| K123937 | ATOM TRANSCAPSULE V-707 | Atom Medical Corporation | 2013-05-23 | Traditional | PDF ↗ |
| K103525 | A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX | International Biomedical, Ltd. | 2011-05-11 | Special | PDF ↗ |
| K103523 | 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | International Biomedical, Ltd. | 2011-05-11 | Special | PDF ↗ |
| K103527 | AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | International Biomedical, Ltd. | 2011-04-15 | Special | PDF ↗ |
| K103524 | VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | International Biomedical, Ltd. | 2011-04-15 | Special | PDF ↗ |
| K081399 | AVIATOR TRANSPORT INCUBATOR | International Biomedical, Ltd. | 2008-06-06 | Special | PDF ↗ |
| K061071 | V-808 ATOM TRANSCAPSULE | Atom Medical, Inc. | 2006-08-29 | Traditional | PDF ↗ |
| K062052 | LMT NOMAG IC 3.0 | Lmt Lammers Medical Technology GmbH | 2006-07-31 | Traditional | PDF ↗ |
| K033565 | LMT NOMAG IC 1,5 | Lmt Lammers Medical Technology GmbH | 2003-11-21 | Abbreviated | PDF ↗ |
| K031096 | MODIFICATION TO TRANSPORT INCUBATOR 185 | International Biomedics, Inc. | 2003-06-24 | Special | PDF ↗ |
| K022876 | MODIFICATION TO INFANT LIFE SUPPORT MODULE-20 | International Biomedical, Inc. | 2002-09-11 | Special | PDF ↗ |
| K001019 | TI500 GLOBE-TROTTER TRANSPORT SYSTEM | Hill-Rom Air-Shields | 2000-04-27 | Traditional | PDF ↗ |
| K941106 | MODEL TI500 ISOLETTE INFANT INCUBATOR | Air-Shields, Inc. | 1994-06-10 | Traditional | PDF ↗ |
| K932417 | FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-IT | Ferno-Washington, Inc. | 1993-09-09 | Traditional | PDF ↗ |
| K931346 | FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT | Ferno | 1993-08-25 | Traditional | PDF ↗ |
| K893624 | PREEMICARE MODEL 2500 TRANSPORT WARMER | Preemicare Corp. | 1989-09-27 | Traditional | PDF ↗ |
| K854065 | INFANT LIFE SUPPORT MODULE-20 | Intl. Biomedics, Inc. | 1986-01-16 | Traditional | PDF ↗ |
| K850496 | TRANSPORT INCUBATOR 185 | Airborne Life Support Systems, Inc. | 1985-05-23 | Traditional | PDF ↗ |
| K831028 | TI-1000 TRANSPORT INCUBATOR | Narco Scientific | 1983-05-09 | Traditional | PDF ↗ |
| K790689 | REVISED BATTERY CHARGER | Vickers America Medical Corp. | 1979-05-29 | Traditional | PDF ↗ |
| K790551 | TRANSPORT INCUBATOR | Narco Air-Shields | 1979-04-24 | Traditional | PDF ↗ |
| K780964 | TRANSPORT INCUBATOR | Cavitron Corp. | 1978-07-27 | Traditional | PDF ↗ |
Product code FPL · Class II · General Hospital. Data: openFDA.