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 |