MORTARA INSTRUMENT, INC. E-SCRIBE

Electrocardiograph

MORTARA INSTRUMENT, INC.

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

Pre-market Notification Details

• Device ID: K930558
• 510k Number: K930558
• Device Name: MORTARA INSTRUMENT, INC. E-SCRIBE
• Classification: Electrocardiograph
• Applicant: MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224
• Contact: Jim Headrick
• Correspondent: Jim Headrick; MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224
• Product Code: DPS
• CFR Regulation Number: 870.2340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-02-03
• Decision Date: 1993-04-27

NIH GUDID Devices

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