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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter (Beta, Gamma) For Clinical Use
510(k) Number K802578
Device Name PACE-4-AUTOMATIC RIA GAMMA-COUTER
Applicant
Philips Medical Systems (Cleveland), Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Philips Medical Systems (Cleveland), Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.2320
Classification Product Code
JJJ  
Date Received10/20/1980
Decision Date 12/18/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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