The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Battery Operated Flow Rate Computer.
Device ID | K760756 |
510k Number | K760756 |
Device Name: | BATTERY OPERATED FLOW RATE COMPUTER |
Classification | Computer, Diagnostic, Pre-programmed, Single-function |
Applicant | 3M HEALTH CARE, SARNS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXG |
CFR Regulation Number | 870.1435 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-10-01 |
Decision Date | 1976-10-15 |