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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 K851277
Device Name MICROSPIRO-SDS
Applicant
Medical Equipment Designs, Inc.
23461 Ridge Rte. Dr., Suite F
Laguna Hills,  CA  92653
Applicant Contact MICHAEL BERG
Correspondent
Medical Equipment Designs, Inc.
23461 Ridge Rte. Dr., Suite F
Laguna Hills,  CA  92653
Correspondent Contact MICHAEL BERG
Regulation Number868.1840
Classification Product Code
BZG  
Date Received04/01/1985
Decision Date 04/19/1985
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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