Cleared Traditional

K901680 - BAUMAN RIGID LARYNGOSCOPE
(FDA 510(k) Clearance)

Jul 1990
Decision
91d
Days
Class 1
Risk

K901680 is an FDA 510(k) clearance for the BAUMAN RIGID LARYNGOSCOPE. This device is classified as a Laryngoscope, Rigid (Class I - General Controls, product code CCW).

Submitted by Palex Intl. SA (Spain, ES). The FDA issued a Cleared decision on July 12, 1990, 91 days after receiving the submission on April 12, 1990.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5540.

Submission Details

510(k) Number K901680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1990
Decision Date July 12, 1990
Days to Decision 91 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

Product Code CCW — Laryngoscope, Rigid
Device Class Class I - General Controls
CFR Regulation 21 CFR 868.5540

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