Cleared Traditional

TRANSONIC FLOWMETER

K872048 · Transonic Systems, Inc. · Cardiovascular
Jun 1988
Decision
390d
Days
Class 2
Risk

About This 510(k) Submission

K872048 is an FDA 510(k) clearance for the TRANSONIC FLOWMETER, 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 June 21, 1988, 390 days after receiving the submission on May 28, 1987. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2100.

Submission Details

510(k) Number K872048 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 1987
Decision Date June 21, 1988
Days to Decision 390 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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