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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 K941252
Device Name RESPIRATORY AND CARDIAC SPECTRAL FREQUENCY SIGNAL PROCESSOR
Applicant
ANSAR
242 SOUTH EIGHTH ST.
PHILIDELPHIA,  PA  19107
Applicant Contact ROBERT G WELCH
Correspondent
ANSAR
242 SOUTH EIGHTH ST.
PHILIDELPHIA,  PA  19107
Correspondent Contact ROBERT G WELCH
Regulation Number870.2300
Classification Product Code
DRT  
Date Received03/15/1994
Decision Date 09/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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