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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 K041327
Device Name MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES
Applicant
MED2000 S.R.L.
55 NORTHERN BLVD., STE 200
GREAT NECK,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
MED2000 S.R.L.
55 NORTHERN BLVD., STE 200
GREAT NECK,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number868.5630
Classification Product Code
CAF  
Date Received05/18/2004
Decision Date 07/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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