AMBULATORY X-12 TELEMETRY MODULE— 510(k) K974149

Substantially Equivalent

Mortara Instrument, Inc.

FDA 510(k) clearance K974149 for AMBULATORY X-12 TELEMETRY MODULE, Substantially Equivalent on 1998-01-08. Applicant: Mortara Instrument, Inc..

Clearance details

Applicant: Mortara Instrument, Inc.
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 1997-11-04
Decision date: 1998-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

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Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.