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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 K772068
Device Name MANIFOLD & NEBULIZER, UNIVERSAL
Applicant
INSPIRON CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
INSPIRON CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5630
Classification Product Code
CAF  
Date Received11/01/1977
Decision Date 11/15/1977
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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