MICROTIME— 510(k) K952616

Substantially Equivalent

Westmed Intl.

FDA 510(k) clearance K952616 for MICROTIME, Substantially Equivalent on 1995-09-27. Applicant: Westmed Intl..

Clearance details

Applicant: Westmed Intl.
Product code: Code BTI
Advisory panel: Anesthesiology
Date received: 1995-06-06
Decision date: 1995-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTI

product code BTI

Death: 25
Malfunction: 1,168
Total: 1,193

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.