H-SCRIBE

Electrocardiograph, Ambulatory, With Analysis Algorithm

MORTARA INSTRUMENT, INC.

The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for H-scribe.

Pre-market Notification Details

• Device ID: K004017
• 510k Number: K004017
• Device Name: H-SCRIBE
• Classification: Electrocardiograph, Ambulatory, With Analysis Algorithm
• Applicant: MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224
• Contact: Harlan L Van Matre
• Correspondent: Harlan L Van Matre; MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224
• Product Code: MLO
• CFR Regulation Number: 870.2800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-12-27
• Decision Date: 2001-06-11

NIH GUDID Devices

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