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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor, bed patient
510(k) Number K873806
Device Name JDM SP2 SENSOR
Applicant
JD MONITORING C/O MACKLER, COOPER AND GIBBS
SUITE 615
1220 L STREET, N.W.
WASHINGTON,  DC  20005
Applicant Contact JEFFREY N GIBBS
Correspondent
JD MONITORING C/O MACKLER, COOPER AND GIBBS
SUITE 615
1220 L STREET, N.W.
WASHINGTON,  DC  20005
Correspondent Contact JEFFREY N GIBBS
Regulation Number880.2400
Classification Product Code
KMI  
Date Received09/18/1987
Decision Date 12/08/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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