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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pneumotachometer
510(k) Number K921178
Device Name PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS
Applicant
Medical Associated Services, Inc.
P.O. Box 530
Hatfield,  PA  19440
Applicant Contact MARK S ALSBERGE
Correspondent
Medical Associated Services, Inc.
P.O. Box 530
Hatfield,  PA  19440
Correspondent Contact MARK S ALSBERGE
Regulation Number868.2550
Classification Product Code
JAX  
Date Received03/09/1992
Decision Date 08/26/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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