The following data is part of a premarket notification filed by Hemedex Incorporated with the FDA for Qflow 500 Perfusion Monitoring System.
| Device ID | K013376 |
| 510k Number | K013376 |
| Device Name: | QFLOW 500 PERFUSION MONITORING SYSTEM |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | HEMEDEX INCORPORATED 7 TIFFANY TRAIL Hopkinton, MA 01748 |
| Contact | Debbie Iampietro |
| Correspondent | Debbie Iampietro HEMEDEX INCORPORATED 7 TIFFANY TRAIL Hopkinton, MA 01748 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-11 |
| Decision Date | 2002-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B238H000107110 | K013376 | 000 |
| B238H000016000 | K013376 | 000 |
| B238H000007100 | K013376 | 000 |