FI-10M— 510(k) K951194

Substantially Equivalent

Pentax Precision Instrument Corp.

FDA 510(k) clearance K951194 for FI-10M, Substantially Equivalent on 1995-04-06. Applicant: Pentax Precision Instrument Corp..

Clearance details

Applicant: Pentax Precision Instrument Corp.
Product code: Code CAL
Advisory panel: Anesthesiology
Date received: 1995-03-16
Decision date: 1995-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miramar, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAL

product code CAL

Malfunction: 885
Total: 885

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.