The following data is part of a premarket notification filed by Synovis Micro Companies Alliance, Inc. with the FDA for Gem Flow Coupler Monitor (gem1020m-2).
| Device ID | K213974 |
| 510k Number | K213974 |
| Device Name: | GEM FLOW COUPLER Monitor (GEM1020M-2) |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | Synovis Micro Companies Alliance, Inc. (a Subsidiary Of Baxter International Inc.) 439 Industrial Lane Birmingham, AL 35211 |
| Contact | Russell Pagano |
| Correspondent | Julie S. Carlston Synovis Micro Companies Alliance, Inc. (a Subsidiary Of Baxter International Inc.) 439 Industrial Lane Birmingham, AL 35211 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-20 |
| Decision Date | 2022-04-20 |