Cleared Traditional

LITEAIRE

K993101 · Thayer Medical Corp. · Anesthesiology
Oct 2000
Decision
406d
Days
Class 2
Risk

About This 510(k) Submission

K993101 is an FDA 510(k) clearance for the LITEAIRE, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Thayer Medical Corp. (Tucson, US). The FDA issued a Cleared decision on October 26, 2000, 406 days after receiving the submission on September 16, 1999. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K993101 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 1999
Decision Date October 26, 2000
Days to Decision 406 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CAF — Nebulizer (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5630

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