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510(k) K920353

Device
ULTRACELL INSTRUMENT WIPE
Applicant
ULTRACELL MEDICAL TECHNOLOGIES, INC.
510(k) number
K920353
Product code
HEP  
Decision
Substantially Equivalent (SESE)
Decision date
1992-09-15
Date received
1992-01-27
Regulation
884.2660
Classification name
Monitor, Blood-flow, Ultrasonic
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GEORGE P KORTEWEG
Address
P.O. Box 326 North Stonington CT US 06359 06359

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
K910462POCKET DOP 3Imex Medical Systems, Inc.1991-06-24

Legacy Summary#

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FDA Review#

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