SAMM

Transmitters And Receivers, Electrocardiograph, Telephone

DART MEDICAL EQUIPMENT

The following data is part of a premarket notification filed by Dart Medical Equipment with the FDA for Samm.

Pre-market Notification Details

• Device ID: K820828
• 510k Number: K820828
• Device Name: SAMM
• Classification: Transmitters And Receivers, Electrocardiograph, Telephone
• Applicant: DART MEDICAL EQUIPMENT 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: DXH
• CFR Regulation Number: 870.2920 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-03-26
• Decision Date: 1982-04-14