The following data is part of a premarket notification filed by Biegler Gmbh with the FDA for Bw685, Bw685s.
| Device ID | K121198 |
| 510k Number | K121198 |
| Device Name: | BW685, BW685S |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | BIEGLER GMBH 24301 WOODSAGE DR Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden BIEGLER GMBH 24301 WOODSAGE DR Bonita Springs, FL 34134 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-19 |
| Decision Date | 2012-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09008247000501 | K121198 | 000 |
| 19008247000843 | K121198 | 000 |