The following data is part of a premarket notification filed by American Mcgaw with the FDA for Mcgaw/drop Watch Flow Monitor.
| Device ID | K853549 |
| 510k Number | K853549 |
| Device Name: | MCGAW/DROP WATCH FLOW MONITOR |
| Classification | Monitor, Electric For Gravity Flow Infusion Systems |
| Applicant | AMERICAN MCGAW P.O. BOX 1187 Santa Ana, CA 92711 |
| Contact | Joyce Williams |
| Correspondent | Joyce Williams AMERICAN MCGAW P.O. BOX 1187 Santa Ana, CA 92711 |
| Product Code | FLN |
| CFR Regulation Number | 880.2420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-26 |
| Decision Date | 1985-11-12 |