FlowMet

Flowmeter, Blood, Cardiovascular

Laser Associated Sciences, Inc.

The following data is part of a premarket notification filed by Laser Associated Sciences, Inc. with the FDA for Flowmet.

Pre-market Notification Details

Device IDK192966
510k NumberK192966
Device Name:FlowMet
ClassificationFlowmeter, Blood, Cardiovascular
Applicant Laser Associated Sciences, Inc. 5171 California Ave., Suite 150 Irvine,  CA  92617
ContactSean White
CorrespondentSean White
Laser Associated Sciences, Inc. 5171 California Ave., Suite 150 Irvine,  CA  92617
Product CodeDPW  
CFR Regulation Number870.2100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-23
Decision Date2020-01-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860001276138 K192966 000
00860001276121 K192966 000
10860001276111 K192966 000
00763000502843 K192966 000

Trademark Results [FlowMet]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FLOWMET
FLOWMET
88342522 5889436 Live/Registered
Laser Associated Sciences, Inc.
2019-03-15
FLOWMET
FLOWMET
79276566 not registered Live/Pending
Ascenz Pte Ltd
2019-11-13

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