EXTERNAL PACEMAKER ANALYZER MODEL PMA-1— 510(k) K903966

Name: FDA 510(k) clearance K903966
Creator: U.S. Food and Drug Administration
Published: 1991-06-19

Substantially Equivalent

Bio-Tek Instruments, Inc.

FDA 510(k) clearance K903966 for EXTERNAL PACEMAKER ANALYZER MODEL PMA-1, Substantially Equivalent on 1991-06-19. Applicant: Bio-Tek Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Tek Instruments, Inc.
Product code: Code DTC
Device class: Class 2
Regulation: 21 CFR 870.3630
Advisory panel: Cardiovascular
Date received: 1990-08-28
Decision date: 1991-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winooski, VT, US

Download summary PDF View on FDA.gov ↗

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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.