FDA Product Code
FDA Product Code KMI — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.2400
510(k) Clearances — 31 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K141877 | LEAF PATIENT MONITORING SYSTEM | Leaf Healthcare, Inc. | 2014-11-10 | Traditional | PDF ↗ |
| K131585 | INTEL-GE CARE INNOVATIONS QUIETCARE | Intel-Ge Care Innovations, LLC | 2013-10-08 | Traditional | PDF ↗ |
| K130752 | DYNASENSE SYSTEM | Centauri Medical, Inc. | 2013-08-15 | Traditional | PDF ↗ |
| K101109 | VIVATRAK | Wireless Medcare, LLC | 2010-07-15 | Traditional | PDF ↗ |
| K090138 | MOBILECARE MONITOR, MODEL 2100 | Aframe Digital, Inc. | 2009-04-24 | Traditional | PDF ↗ |
| K942770 | ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR | Ultimate Development Corp. | 1994-12-23 | Traditional | PDF ↗ |
| K943481 | INFORMER PLUS | Micro-Tech Medical, Inc. | 1994-11-02 | Traditional | PDF ↗ |
| K933552 | PM-PAGER | Hill Engineering | 1994-09-22 | Traditional | PDF ↗ |
| K934344 | HOME AMB-ALERT | Medway | 1994-04-29 | Traditional | PDF ↗ |
| K940405 | TELETOM | Berchtold Holding GmbH | 1994-04-14 | Traditional | PDF ↗ |
| K924433 | SENIOR TECH TABS 88 TRANS RA1/WRA1/R1 ANN TYPE CR1 | Senior Technologies, Inc. | 1993-06-24 | Traditional | PDF ↗ |
| K925529 | WANDER CARE | Care Electronics, Inc. | 1993-06-16 | Traditional | PDF ↗ |
| K920206 | POSEY SITTER | J. T. Posey Co. | 1992-05-14 | Traditional | PDF ↗ |
| K914859 | BARTRONIX IN-BED ACTIVITY MONITOR | Bartronix | 1992-04-13 | Traditional | PDF ↗ |
| K911079 | AMB-ALERT | Medway | 1991-09-13 | Traditional | PDF ↗ |
| K905586 | RSVP RF-2000 | Tactilitics, Inc. | 1991-04-01 | Traditional | PDF ↗ |
| K905421 | EXIT ALARM | Alertcare | 1991-02-12 | Traditional | PDF ↗ |
| K901969 | ALERT BED ALARM SYSTEM | Alertronics, Inc. | 1990-09-12 | Traditional | PDF ↗ |
| K901330 | THE MONITOR ELECTRONIC BED ALARM SYSTEM | The Monitor Corp. | 1990-08-30 | Traditional | PDF ↗ |
| K883390 | PMD SYSTEM-20 | Datatek, Inc. | 1988-10-25 | Traditional | PDF ↗ |
| K873806 | JDM SP2 SENSOR | Jd Monitoring C/O Mackler, Cooper and Gibbs | 1987-12-08 | Traditional | PDF ↗ |
| K872358 | STA-PUT | Design Technologies, Inc. | 1987-08-06 | Traditional | PDF ↗ |
| K871203 | BED PATIENT PRESENCE MONITOR | Human Technologies, Inc. | 1987-05-26 | Traditional | PDF ↗ |
| K864827 | RSVP SYSTEMS, SERIES I, BED-PATIENT MONITOR | Tactilitics, Inc. | 1987-01-21 | Traditional | PDF ↗ |
| K860537 | THE CELL CARE SYSTEM | The Clell Corp. | 1986-04-17 | Traditional | PDF ↗ |
| K854950 | BED PATIENT MONITOR | Clearview Electronics Corp. | 1986-03-25 | Traditional | PDF ↗ |
| K841671 | FALL-SAFE MONITOR | Fsm Corp. | 1984-07-03 | Traditional | PDF ↗ |
| K841672 | FALL-SAFE VEST | Fsm Corp. | 1984-07-03 | Traditional | PDF ↗ |
| K840295 | AMBULARM | Rigi Systems, Inc. | 1984-05-07 | Traditional | PDF ↗ |
| K823926 | BED-CHECK: II-IFAC | Bed-Check Corp. | 1983-04-18 | Traditional | PDF ↗ |
| K770695 | MONITOR, BED, TECHNOLICS | Technolics, Inc. | 1977-07-14 | Traditional | PDF ↗ |
Product code KMI · Class I · General Hospital. Data: openFDA.