PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630— 510(k) K823334

Substantially Equivalent

Psitron

FDA 510(k) clearance K823334 for PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630, Substantially Equivalent on 1983-03-24. Applicant: Psitron.

Clearance details

Applicant: Psitron
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 1982-11-08
Decision date: 1983-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRS

product code DRS

Death: 8
Malfunction: 776
Total: 784

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.