The following data is part of a premarket notification filed by Biegler Medical Products, Inc. with the FDA for Biegler Bw385l Blood & Infusion Warmer.
| Device ID | K954769 |
| 510k Number | K954769 |
| Device Name: | BIEGLER BW385L BLOOD & INFUSION WARMER |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | BIEGLER MEDICAL PRODUCTS, INC. 7 IRIS COURT P.O. BOX 160 Carlisle, Ontario, CA L0r 1h0 |
| Contact | Martin Costello |
| Correspondent | Martin Costello BIEGLER MEDICAL PRODUCTS, INC. 7 IRIS COURT P.O. BOX 160 Carlisle, Ontario, CA L0r 1h0 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-16 |
| Decision Date | 1996-08-08 |
| Summary: | summary |