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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Meter, Peak Flow, Spirometry
510(k) Number K851265
Device Name PEAK FLOWMETERS FOR SPIROMETRY
Applicant
Solcoor, Inc.
1655 N. Ft. Myer Dr. Suite 700
Arlington,  VA  22209
Applicant Contact BARBARA A MARSDEN
Correspondent
Solcoor, Inc.
1655 N. Ft. Myer Dr. Suite 700
Arlington,  VA  22209
Correspondent Contact BARBARA A MARSDEN
Regulation Number868.1860
Classification Product Code
BZH  
Date Received03/29/1985
Decision Date 10/29/1985
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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