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510(k) K910462

Device
POCKET DOP 3
Applicant
IMEX MEDICAL SYSTEMS, INC.
510(k) number
K910462
Product code
HEP  
Decision
Substantially Equivalent (SESE)
Decision date
1991-06-24
Date received
1991-02-04
Regulation
884.2660
Classification name
Monitor, Blood-flow, Ultrasonic
Medical specialty
Obstetrics/Gynecology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ED BISTRICK
Address
6355 Joyce Dr. Golden CO US 80403 80403

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HEP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K101960SONOTRAX SERIES ULTRASONIC POCKET DOPPLEREdan Instruments, Inc.2010-08-10
K023082BABYCAREBionet Company, Ltd.2003-03-03
K920353ULTRACELL INSTRUMENT WIPEUltracell Medical Technologies, Inc.1992-09-15

Legacy Summary#

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FDA Review#

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