510(k) K903625

DOPPLER NEEDLE AND FLOW MONITOR by Peripheral Systems Group — Product Code DPW

K903625 is an FDA 510(k) premarket notification submitted by Peripheral Systems Group for the device "DOPPLER NEEDLE AND FLOW MONITOR". The FDA issued a decision of Substantially Equivalent on November 7, 1990. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Peripheral Systems Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1990
Date Received
August 10, 1990
Clearance Type
Traditional
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