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510(k) K041327

MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES by Med2000 S.R.L. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2004
Date Received
May 18, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

Other clearances by Med2000 S.R.L.

  • K041974 — MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER (August 24, 2004)
  • K031908 — MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 (January 14, 2004)

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