MERCURY

Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

MENNEN MEDICAL, INC.

The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Mercury.

Pre-market Notification Details

• Device ID: K940081
• 510k Number: K940081
• Device Name: MERCURY
• Classification: Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
• Applicant: MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031
• Contact: Ronald A Brandt
• Correspondent: Ronald A Brandt; MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031
• Product Code: DRT
• CFR Regulation Number: 870.2300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-01-07
• Decision Date: 1995-04-12