EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100— 510(k) K961582

Substantially Equivalent

North American Technical Services Corp.

FDA 510(k) clearance K961582 for EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100, Substantially Equivalent on 1996-11-08. Applicant: North American Technical Services Corp..

Clearance details

Applicant: North American Technical Services Corp.
Product code: Code DTC
Advisory panel: Cardiovascular
Date received: 1996-04-24
Decision date: 1996-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sound Beach, NY, US

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Adverse events under product code DTC

product code DTC

Injury: 136
Malfunction: 3,400
Total: 3,536

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.