Floscope Microdop

FDA 510(k) K910441 · Advance Medical Device, Inc.

Substantially Equivalent

510(k) numberK910441

Submission

Device name
Floscope Microdop
Applicant
Advance Medical Device, Inc.
Berlin, NJ, US
Received
January 31, 1991
Decision date
March 21, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DPT – Probe, Blood-Flow, Extravascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2120
Specialty
Cardiovascular

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K903744Physician's ChoiceHIB · Traditional 09/12/1990SE

Questions and answers

When was Floscope Microdop cleared by the FDA?

Floscope Microdop (K910441) received a 510(k) decision of Substantially Equivalent on March 21, 1991, 49 days after the submission was received.

What is the product code of K910441?

The FDA product code is DPT – Probe, Blood-Flow, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2120.