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 |
19008247000249 | K121198 | 000 |
19008247000232 | K121198 | 000 |