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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Data
510(k) Number K982487
Device Name CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO
Applicant
CARDIOPULMONARY TECHNOLOGIES, INC.
W 260 N 9311 HIGHWAY 164
COLGATE,  WI  53017 -9600
Applicant Contact MARK S STORSVED
Correspondent
CARDIOPULMONARY TECHNOLOGIES, INC.
W 260 N 9311 HIGHWAY 164
COLGATE,  WI  53017 -9600
Correspondent Contact MARK S STORSVED
Regulation Number868.1880
Classification Product Code
BZC  
Date Received07/17/1998
Decision Date 10/14/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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