Cleared Traditional

THE SPIRA ELEKTRO 2

K871151 · Warren E. Collins, Inc. · Anesthesiology
May 1987
Decision
53d
Days
Class 1
Risk

About This 510(k) Submission

K871151 is an FDA 510(k) clearance for the THE SPIRA ELEKTRO 2, a Nebulizer, Medicinal, Non-ventilatory (atomizer) (Class I — General Controls, product code CCQ), submitted by Warren E. Collins, Inc. (Braintree, US). The FDA issued a Cleared decision on May 15, 1987, 53 days after receiving the submission on March 23, 1987. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5640.

Submission Details

510(k) Number K871151 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 1987
Decision Date May 15, 1987
Days to Decision 53 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CCQ — Nebulizer, Medicinal, Non-ventilatory (atomizer)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5640

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