Cleared Traditional

K925459 - GS-MODULAR (GOLD STANDARD - MODULAR)
(FDA 510(k) Clearance)

K925459 · Warren E. Collins, Inc. · Anesthesiology
Feb 1994
Decision
463d
Days
Class 2
Risk

K925459 is an FDA 510(k) clearance for the GS-MODULAR (GOLD STANDARD - MODULAR), 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 February 4, 1994, 463 days after receiving the submission on October 29, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K925459 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 1992
Decision Date February 04, 1994
Days to Decision 463 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

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