FDA Product Code
FDA Product Code BSB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.9205
510(k) Clearances — 14 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K112639 | THE BELMONT BUDDY LITE FLUID WARMER | Belmont Instrument Corp. | 2011-11-16 | Special | PDF ↗ |
| K090508 | THE BELMONT BUDDY LITE FLUID WARMER | Belmont Instrument Corp. | 2009-03-26 | Special | PDF ↗ |
| K062774 | BELMONT BUDDY PLUS FLUID WARMER | Belmont Instrument Corp. | 2006-10-19 | Special | PDF ↗ |
| K052547 | BELMONT BUDDY FLUID WARMER | Belmont Instrument Corp. | 2005-10-13 | Special | PDF ↗ |
| K031478 | MICROHEATER | Belmont Instrument Corp. | 2003-07-02 | Traditional | PDF ↗ |
| K020060 | ASTOFLO | Nats Corp. | 2002-03-05 | Abbreviated | PDF ↗ |
| K012031 | MODIFICATION TO THERMAL ANGEL | Estill Medical Technologies, Inc. | 2001-07-26 | Special | PDF ↗ |
| K991159 | PRISMATHERM II, ASTOLINE | Stihler Electronic GmbH | 1999-09-03 | Abbreviated | PDF ↗ |
| K991160 | ASTOTHERM PLUS, ASTOTUBES, ASTOLINE | Stihler Electronic GmbH | 1999-09-02 | Abbreviated | PDF ↗ |
| K984640 | THERMAL ANGEL | Estill Medical Technologies, Inc. | 1999-07-01 | Traditional | PDF ↗ |
| K973741 | BAIR HUGGER BLOOD/FLUID WARMER | Augustine Medical, Inc. | 1998-04-30 | Traditional | PDF ↗ |
| K953741 | THERMACYL BLOOD/FLUID WARMER | Baxter Healthcare Corp | 1996-06-26 | Traditional | PDF ↗ |
| K770232 | BLOOD/FLUID WARMER MODEL DW-1000A | Gorman Rupp Industries | 1977-02-14 | Traditional | PDF ↗ |
| K760012 | BLOOD WARMER (CODE 4R4305) | Travenol Laboratories, S.A. | 1976-07-16 | Traditional | PDF ↗ |
Product code BSB · Class II · Hematology. Data: openFDA.