FI-10P— 510(k) K951195

Name: FDA 510(k) clearance K951195
Creator: U.S. Food and Drug Administration
Published: 1995-04-06

Substantially Equivalent

Pentax Precision Instrument Corp.

FDA 510(k) clearance K951195 for FI-10P, Substantially Equivalent on 1995-04-06. Applicant: Pentax Precision Instrument Corp.. Device class: 1.

Clearance details

Applicant: Pentax Precision Instrument Corp.
Product code: Code CAL
Device class: Class 1
Regulation: 21 CFR 868.5530
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 ↗

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K850978 — OLYMPUS LF-1 INTUBATION SCOPE1985-05-23
K802331 — AO FLEXIBLE LARYNGOSCOPE, #LS-71980-10-10

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K031789 — EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE2003-08-08
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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.