Cleared Traditional

ADVANCE LASER FLOWMETER, ALF 21

K903633 · Transonic Systems, Inc. · Cardiovascular
Oct 1990
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K903633 is an FDA 510(k) clearance for the ADVANCE LASER FLOWMETER, ALF 21, a Flowmeter, Blood, Cardiovascular (Class II — Special Controls, product code DPW), submitted by Transonic Systems, Inc. (Ithaca, US). The FDA issued a Cleared decision on October 9, 1990, 60 days after receiving the submission on August 10, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2100.

Submission Details

510(k) Number K903633 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 1990
Decision Date October 09, 1990
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DPW — Flowmeter, Blood, Cardiovascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2100

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