Cleared Traditional

IMV W/BAG & TUBING #M-508

K791905 · Mem Medical, Inc. · Anesthesiology
Oct 1979
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K791905 is an FDA 510(k) clearance for the IMV W/BAG & TUBING #M-508, a Attachment, Intermittent Mandatory Ventilation (imv) (Class II — Special Controls, product code CBO), submitted by Mem Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 9, 1979, 14 days after receiving the submission on September 25, 1979. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5955.

Submission Details

510(k) Number K791905 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1979
Decision Date October 09, 1979
Days to Decision 14 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