SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR

Flowmeter, Blood, Cardiovascular

KOVEN TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Koven Technology, Inc. with the FDA for Smartdop 30 Bi-directional Blood Flow Detector.

Pre-market Notification Details

• Device ID: K942613
• 510k Number: K942613
• Device Name: SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR
• Classification: Flowmeter, Blood, Cardiovascular
• Applicant: KOVEN TECHNOLOGY, INC. 300 BROOKES DR. SUITE 105 St. Louis, MO 63042
• Contact: Paul G Koven
• Correspondent: Paul G Koven; KOVEN TECHNOLOGY, INC. 300 BROOKES DR. SUITE 105 St. Louis, MO 63042
• Product Code: DPW
• CFR Regulation Number: 870.2100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-06-02
• Decision Date: 1994-12-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00894912002913	K942613	000
00894912002203	K942613	000
00894912002197	K942613	000