BIOLOG

Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

MICROMEDICAL

The following data is part of a premarket notification filed by Micromedical with the FDA for Biolog.

Pre-market Notification Details

• Device ID: K895534
• 510k Number: K895534
• Device Name: BIOLOG
• Classification: Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
• Applicant: MICROMEDICAL 47 W. HANOVER ST. SUITE 4 Gettysburg, PA 17325
• Contact: Wesley Kulp
• Correspondent: Wesley Kulp; MICROMEDICAL 47 W. HANOVER ST. SUITE 4 Gettysburg, PA 17325
• Product Code: DRT
• CFR Regulation Number: 870.2300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-09-13
• Decision Date: 1990-03-19