Cleared Traditional

K831780 - METABOLIC EXERCISE TESTING SYSTEM
(FDA 510(k) Clearance)

K831780 · Warren E. Collins, Inc. · Anesthesiology
Sep 1983
Decision
102d
Days
Class 2
Risk

K831780 is an FDA 510(k) clearance for the METABOLIC EXERCISE TESTING SYSTEM, a Computer, Oxygen-uptake (Class II — Special Controls, product code BZL), submitted by Warren E. Collins, Inc. (Walker, US). The FDA issued a Cleared decision on September 12, 1983, 102 days after receiving the submission on June 2, 1983. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1730.

Submission Details

510(k) Number K831780 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 1983
Decision Date September 12, 1983
Days to Decision 102 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

Product Code BZL — Computer, Oxygen-uptake
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1730