Cleared Traditional

IMV MANIFOLDS

K811908 · Airlife, Inc. · Anesthesiology
Jul 1981
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K811908 is an FDA 510(k) clearance for the IMV MANIFOLDS, a Attachment, Intermittent Mandatory Ventilation (imv) (Class II — Special Controls, product code CBO), submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 16, 1981, 15 days after receiving the submission on July 1, 1981. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5955.

Submission Details

510(k) Number K811908 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1981
Decision Date July 16, 1981
Days to Decision 15 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CBO — Attachment, Intermittent Mandatory Ventilation (imv)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5955