INSTANT REPLAY

Transmitters And Receivers, Electrocardiograph, Telephone

INSTROMEDIX, INC.

The following data is part of a premarket notification filed by Instromedix, Inc. with the FDA for Instant Replay.

Pre-market Notification Details

• Device ID: K840587
• 510k Number: K840587
• Device Name: INSTANT REPLAY
• Classification: Transmitters And Receivers, Electrocardiograph, Telephone
• Applicant: INSTROMEDIX, INC. 10950 SW FIFTH AVE. Beaverton, OR 97005
• Contact: Semler
• Correspondent: Semler; INSTROMEDIX, INC. 10950 SW FIFTH AVE. Beaverton, OR 97005
• Product Code: DXH
• CFR Regulation Number: 870.2920 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-02-08
• Decision Date: 1984-10-26