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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
510(k) Number K872315
Device Name MISTMASTER
Applicant
Sonora Respiratory Products, Inc.
1180-Z Star Rte.
Sonora,  CA  95370
Applicant Contact EDWARD J SVOBODA
Correspondent
Sonora Respiratory Products, Inc.
1180-Z Star Rte.
Sonora,  CA  95370
Correspondent Contact EDWARD J SVOBODA
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received06/17/1987
Decision Date 09/11/1987
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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