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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spirometer, diagnostic
510(k) Number K001528
Device Name PC FLOW +
Applicant
SPIROMETRICS MEDICAL EQUIPMENT CO.
49 PLAIN ST.
N. ATTLEBORO,  MA  02760 -4153
Applicant Contact JAMES R VEALE
Correspondent
SPIROMETRICS MEDICAL EQUIPMENT CO.
49 PLAIN ST.
N. ATTLEBORO,  MA  02760 -4153
Correspondent Contact JAMES R VEALE
Regulation Number868.1840
Classification Product Code
BZG  
Date Received05/17/2000
Decision Date 01/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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