The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Perfusor Compact With Fm System.
Device ID | K022575 |
510k Number | K022575 |
Device Name: | PERFUSOR COMPACT WITH FM SYSTEM |
Classification | Pump, Infusion |
Applicant | B. BRAUN MEDICAL, INC. 1601 WALLACE DR., SUITE 150 Carrollton, TX 75006 |
Contact | Linda Morgan |
Correspondent | Linda Morgan B. BRAUN MEDICAL, INC. 1601 WALLACE DR., SUITE 150 Carrollton, TX 75006 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-08-02 |
Decision Date | 2002-08-21 |
Summary: | summary |