HEARTPRINT

Recorder, Magnetic Tape, Medical

MEDATA, INC.

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

Pre-market Notification Details

• Device ID: K942862
• 510k Number: K942862
• Device Name: HEARTPRINT
• Classification: Recorder, Magnetic Tape, Medical
• Applicant: MEDATA, INC. P.O. BOX 2112, Thousand Oaks, CA 91358
• Contact: John A Humphrey
• Correspondent: John A Humphrey; MEDATA, INC. P.O. BOX 2112, Thousand Oaks, CA 91358
• Product Code: DSH
• CFR Regulation Number: 870.2800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-06-17
• Decision Date: 1995-01-18