COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER

Monitor, Heart Rate, Fetal, Ultrasonic

COROMETRICS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Corometrics Medical Systems, Inc. with the FDA for Corometrics Model 5700 And 2264 Watertight Transducer.

Pre-market Notification Details

• Device ID: K982651
• 510k Number: K982651
• Device Name: COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER
• Classification: Monitor, Heart Rate, Fetal, Ultrasonic
• Applicant: COROMETRICS MEDICAL SYSTEMS, INC. 61 BARNES PARK RD. NORTH P.O. BOX 333 Wallingford, CT 06492
• Contact: Richard Cehovsky
• Correspondent: Richard Cehovsky; COROMETRICS MEDICAL SYSTEMS, INC. 61 BARNES PARK RD. NORTH P.O. BOX 333 Wallingford, CT 06492
• Product Code: HEL
• CFR Regulation Number: 884.2660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-07-30
• Decision Date: 1998-12-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682142571	K982651	000
00840682142564	K982651	000
00840682104296	K982651	000
00840682104227	K982651	000
00840682104210	K982651	000
00840682104111	K982651	000