The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for Avi Model 3100 Infusion Pump.
Device ID | K923068 |
510k Number | K923068 |
Device Name: | AVI MODEL 3100 INFUSION PUMP |
Classification | Pump, Infusion |
Applicant | 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
Contact | Suedkamp |
Correspondent | Suedkamp 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-25 |
Decision Date | 1993-04-20 |