KING OF HEARTS

Transmitters And Receivers, Electrocardiograph, Telephone

INSTROMEDIX, INC.

The following data is part of a premarket notification filed by Instromedix, Inc. with the FDA for King Of Hearts.

Pre-market Notification Details

• Device ID: K880626
• 510k Number: K880626
• Device Name: KING OF HEARTS
• Classification: Transmitters And Receivers, Electrocardiograph, Telephone
• Applicant: INSTROMEDIX, INC. ONE TECHNOLOGY CENTER 7431 N.E. EVERGREEN PARKWAY Hillsboro, OR 97124 -5898
• Contact: Semler, M.d.
• Correspondent: Semler, M.d.; INSTROMEDIX, INC. ONE TECHNOLOGY CENTER 7431 N.E. EVERGREEN PARKWAY Hillsboro, OR 97124 -5898
• Product Code: DXH
• CFR Regulation Number: 870.2920 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-02-16
• Decision Date: 1988-04-11