Cleared Traditional

FI-10M

K951194 · Pentax Precision Instrument Corp. · Anesthesiology
Apr 1995
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K951194 is an FDA 510(k) clearance for the FI-10M, a Laryngoscope, Non-rigid (Class I — General Controls, product code CAL), submitted by Pentax Precision Instrument Corp. (Miramar, US). The FDA issued a Cleared decision on April 6, 1995, 21 days after receiving the submission on March 16, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5530.

Submission Details

510(k) Number K951194 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 1995
Decision Date April 06, 1995
Days to Decision 21 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAL — Laryngoscope, Non-rigid
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5530

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