Floscope Vascular Lab.

FDA 510(k) K905157 · Advance Medical Device, Inc.

Substantially Equivalent

510(k) numberK905157

Submission

Device name
Floscope Vascular Lab.
Applicant
Advance Medical Device, Inc.
Camden, NJ, US
Received
November 16, 1990
Decision date
March 15, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JOP – Transducer, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2880
Specialty
Cardiovascular

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More from Echocath, Inc.

510(k)DeviceDecision
K964697Amd Home Health Monitor System and Amd Monitoring StationDXN · Traditional 02/11/1997SE
K943200Floscope Super Vascular LabJAF · Traditional 11/21/1995SE
K910441Floscope MicrodopDPT · Traditional 03/21/1991SE
K903744Physician's ChoiceHIB · Traditional 09/12/1990SE

Questions and answers

When was Floscope Vascular Lab. cleared by the FDA?

Floscope Vascular Lab. (K905157) received a 510(k) decision of Substantially Equivalent on March 15, 1991, 119 days after the submission was received.

What is the product code of K905157?

The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.