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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
510(k) Number K990123
Device Name PVR-100/VASOGRAM
Applicant
Vasocor, Inc.
7705 NW 48th St., Suite 120
Miami,  FL  33166
Applicant Contact JEFF RAINES
Correspondent
Vasocor, Inc.
7705 NW 48th St., Suite 120
Miami,  FL  33166
Correspondent Contact JEFF RAINES
Regulation Number870.2780
Classification Product Code
JOM  
Date Received01/13/1999
Decision Date 04/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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