ADVANCE LASER FLOWMETER, ALF 21

Flowmeter, Blood, Cardiovascular

TRANSONIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Transonic Systems, Inc. with the FDA for Advance Laser Flowmeter, Alf 21.

Pre-market Notification Details

Device IDK903633
510k NumberK903633
Device Name:ADVANCE LASER FLOWMETER, ALF 21
ClassificationFlowmeter, Blood, Cardiovascular
Applicant TRANSONIC SYSTEMS, INC. WARREN RD. BUSINESS PARK 34 DUTCH MILL RD. Ithaca,  NY  14850
ContactCornelis J Drost
CorrespondentCornelis J Drost
TRANSONIC SYSTEMS, INC. WARREN RD. BUSINESS PARK 34 DUTCH MILL RD. Ithaca,  NY  14850
Product CodeDPW  
CFR Regulation Number870.2100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-08-10
Decision Date1990-10-09

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