PRINCE

Transmitters And Receivers, Electrocardiograph, Telephone

INSTROMEDIX, INC.

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

Pre-market Notification Details

• Device ID: K935586
• 510k Number: K935586
• Device Name: PRINCE
• Classification: Transmitters And Receivers, Electrocardiograph, Telephone
• Applicant: INSTROMEDIX, INC. ONE TECHNOLOGY CENTER 7431 N.E. EVERGREEN PARKWAY Hillsboro, OR 97124 -5898
• Contact: Herbert J Semler
• Correspondent: Herbert J Semler; 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: 1993-11-10
• Decision Date: 1994-11-08