The following data is part of a premarket notification filed by Merge Healthcare Incorporated with the FDA for Merge Hemo.
| Device ID | K152864 |
| 510k Number | K152864 |
| Device Name: | Merge Hemo |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | MERGE HEALTHCARE INCORPORATED 900 WALNUT RIDGE DRIVE Hartland, WI 53029 |
| Contact | Mike Diedrick |
| Correspondent | Carol Nakagawa MERGE HEALTHCARE INCORPORATED 6303 AIRPORT ROAD, SUITE 500 Mississauga, CA L4v1r8 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-30 |
| Decision Date | 2016-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842000100034 | K152864 | 000 |
| 00842000100430 | K152864 | 000 |
| 00842000100874 | K152864 | 000 |
| 00842000100966 | K152864 | 000 |
| 00842000100447 | K152864 | 000 |
| 00842000100027 | K152864 | 000 |