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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 K891672
Device Name PUL-TRON 100K PROFESSIONAL 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 Number868.1840
Classification Product Code
BZG  
Date Received03/21/1989
Decision Date 06/16/1989
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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