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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K854198
Device Name PE-3000 PULSE RATE MONITOR
Applicant
Quantum Life Systems, Inc.
Rd 1, Box 253
Hillcrest Dr.
Great Meadows,  NJ  07838
Applicant Contact LINDA D BAKER
Correspondent
Quantum Life Systems, Inc.
Rd 1, Box 253
Hillcrest Dr.
Great Meadows,  NJ  07838
Correspondent Contact LINDA D BAKER
Regulation Number870.2300
Classification Product Code
DRT  
Date Received10/15/1985
Decision Date 03/13/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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