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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 K896300
Device Name LDW SPIROMETRY SYSTEM
Applicant
LANPHER DIAGNOSTIC WORKSTATIONS, INC.
50 WINCHESTER DR.
ATHERTON,  CA  94025
Applicant Contact TED W LANPHER
Correspondent
LANPHER DIAGNOSTIC WORKSTATIONS, INC.
50 WINCHESTER DR.
ATHERTON,  CA  94025
Correspondent Contact TED W LANPHER
Regulation Number868.1840
Classification Product Code
BZG  
Date Received10/30/1989
Decision Date 04/03/1990
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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