Pocket Dop 3

FDA 510(k) K910462 · Imex Medical Systems, Inc.

Substantially Equivalent

510(k) numberK910462

Submission

Device name
Pocket Dop 3
Applicant
Imex Medical Systems, Inc.
Golden, CO, US
Received
February 4, 1991
Decision date
June 24, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HEP – Monitor, Blood-Flow, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 884.2660
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HEP

510(k)DeviceApplicantDecision
K101960Sonotrax Series Ultrasonic Pocket DopplerHEP · Special Edan Instruments, Inc.08/10/2010SE
K023082BabycareHEP · Abbreviated Bionet Company, Ltd.03/03/2003SE
K920353Ultracell Instrument WipeHEP · Traditional Ultracell Medical Technologies, Inc.09/15/1992SE

More from Ultracell Medical Technologies, Inc.

510(k)DeviceDecision
K973556Imex Medical Systems, Inc. Imexlab 9000IYN · Traditional 04/24/1998SE
K973562Imex Medical Systems, Inc. Imexlab 9100IYN · Traditional 04/15/1998SE
K973336Imex StethodopJAF · Traditional 02/05/1998SE
K970156Imex Futuraldop ProIYO · Traditional 04/04/1997SE
K942243Imex 8000 Personal Cascular LabIYO · Traditional 11/03/1995SE
K944196Imwxdop IrJAF · Traditional 05/12/1995SE
K942441Imexdop Ct+JAF · Traditional 08/23/1994SE
K901593Imex Dop-Tone IIKNG · Traditional 07/02/1990SE
K896613Flat Vascular ProbeDPW · Traditional 02/16/1990SE
K882138Imexlab 3000 Vascular Diagnostic RecorderDPW · Traditional 11/07/1988SE

Questions and answers

When was Pocket Dop 3 cleared by the FDA?

Pocket Dop 3 (K910462) received a 510(k) decision of Substantially Equivalent on June 24, 1991, 140 days after the submission was received.

What is the product code of K910462?

The FDA product code is HEP – Monitor, Blood-Flow, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 884.2660.