Cleared Traditional

COLLINS PNEUMOTACH PFT SYSTEM

K861227 · Warren E. Collins, Inc. · Anesthesiology
Jun 1986
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K861227 is an FDA 510(k) clearance for the COLLINS PNEUMOTACH PFT SYSTEM, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Warren E. Collins, Inc. (Braintree, US). The FDA issued a Cleared decision on June 5, 1986, 65 days after receiving the submission on April 1, 1986. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K861227 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 1986
Decision Date June 05, 1986
Days to Decision 65 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BZG — Spirometer, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1840