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510(k) K904376

Device
ANEROID BLOOD PRESSURE GAUGE
Applicant
BIOMEDICAL DYNAMICS, INC.
510(k) number
K904376
Product code
FCY  
Decision
Substantially Equivalent (SESE)
Decision date
1990-12-20
Date received
1990-09-25
Regulation
876.1500
Classification name
Bulb, Inflation, For Endoscope
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MATTHEW BELLIN
Address
12250 Nicollet Ave. Burnsville MN US 55337 55337

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FCY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K093718ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003Zutron Medical, LLC2010-02-22
K900016TRANS/R - FP(3)CIVCO Medical Instruments Co., Inc.1990-06-11

Legacy Summary#

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FDA Review#

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