Cleared Traditional

PRECISION MEDICAL DISPOSABLE HUMIDIFIER

K902970 · Precision Medical, Inc. · Anesthesiology
Aug 1990
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K902970 is an FDA 510(k) clearance for the PRECISION MEDICAL DISPOSABLE HUMIDIFIER, a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Precision Medical, Inc. (Bath, US). The FDA issued a Cleared decision on August 14, 1990, 39 days after receiving the submission on July 6, 1990. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.

Submission Details

510(k) Number K902970 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 1990
Decision Date August 14, 1990
Days to Decision 39 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BTT — Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5450

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