VITALOG PMS-8 MONITOR— 510(k) K812739

Substantially Equivalent

Vitalog Corp.

FDA 510(k) clearance K812739 for VITALOG PMS-8 MONITOR, Substantially Equivalent on 1981-12-29. Applicant: Vitalog Corp..

Clearance details

Applicant: Vitalog Corp.
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 1981-09-29
Decision date: 1981-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.