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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Predicted Values, Pulmonary Function
510(k) Number K932278
Device Name PFM PROFESSIONAL 7000 SPIROMETER
Applicant
Advanced Medical Systems, Inc.
C/O C.G. Bundy Associates
6470 Riverview Ter.
Minneapolis,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
Advanced Medical Systems, Inc.
C/O C.G. Bundy Associates
6470 Riverview Ter.
Minneapolis,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number868.1890
Classification Product Code
BTY  
Date Received05/12/1993
Decision Date 12/17/1993
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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