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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K800830
Device Name SIEMENS-ELECTROGERATE GMBH MICRO-INHALER
Applicant
MACBETH SALES CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MACBETH SALES CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5630
Classification Product Code
CAF  
Date Received04/14/1980
Decision Date 06/30/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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