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510(k) K183574

SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes by Huntleigh Healthcare , Ltd. — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2019
Date Received
December 21, 2018
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
Review Panel
CV
Submission Type

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