Cleared Traditional

PFT GASES

K781523 · Gardner Cryogenics · Anesthesiology
Dec 1978
Decision
87d
Days
Class 1
Risk

About This 510(k) Submission

K781523 is an FDA 510(k) clearance for the PFT GASES, a Flowmeter, Calibration, Gas (Class I — General Controls, product code BXY), submitted by Gardner Cryogenics (Mchenry, US). The FDA issued a Cleared decision on December 1, 1978, 87 days after receiving the submission on September 5, 1978. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2350.

Submission Details

510(k) Number K781523 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 1978
Decision Date December 01, 1978
Days to Decision 87 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BXY — Flowmeter, Calibration, Gas
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.2350