Cleared Traditional

AMBU HAND POWER SUCTION PUMP

K992902 · Ambu, Inc. · Anesthesiology
Oct 1999
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K992902 is an FDA 510(k) clearance for the AMBU HAND POWER SUCTION PUMP, a Catheters, Suction, Tracheobronchial (Class I — General Controls, product code BSY), submitted by Ambu, Inc. (Linthicum, US). The FDA issued a Cleared decision on October 25, 1999, 56 days after receiving the submission on August 30, 1999. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6810.

Submission Details

510(k) Number K992902 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 1999
Decision Date October 25, 1999
Days to Decision 56 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BSY — Catheters, Suction, Tracheobronchial
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.6810

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