Flowguard Device

FDA 510(k) K013803 · Biosonix , Ltd.

Substantially Equivalent

510(k) numberK013803

Submission

Device name
Flowguard Device
Applicant
Biosonix , Ltd.
Kfar Saba, IL
Received
November 15, 2001
Decision date
February 13, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DPW – Flowmeter, Blood, Cardiovascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2100
Specialty
Cardiovascular

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Questions and answers

When was Flowguard Device cleared by the FDA?

Flowguard Device (K013803) received a 510(k) decision of Substantially Equivalent on February 13, 2002, 90 days after the submission was received.

What is the product code of K013803?

The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.