Cleared Abbreviated

PM 1800 CONSERVING DEVICE

K001412 · Precision Medical, Inc. · Anesthesiology
Mar 2001
Decision
320d
Days
Class 2
Risk

About This 510(k) Submission

K001412 is an FDA 510(k) clearance for the PM 1800 CONSERVING DEVICE, a Conserver, Oxygen (Class II — Special Controls, product code NFB), submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on March 20, 2001, 320 days after receiving the submission on May 4, 2000. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K001412 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 2000
Decision Date March 20, 2001
Days to Decision 320 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code NFB — Conserver, Oxygen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

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