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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 K002499
Device Name BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE
Applicant
BRENTWOOD MEDICAL TECHNOLOGY CORP.
3300 FUJITA ST.
TORRANCE,  CA  90505
Applicant Contact GLEN MIZELLE
Correspondent
BRENTWOOD MEDICAL TECHNOLOGY CORP.
3300 FUJITA ST.
TORRANCE,  CA  90505
Correspondent Contact GLEN MIZELLE
Regulation Number868.1840
Classification Product Code
BZG  
Date Received08/14/2000
Decision Date 11/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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