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510(k) K894138

MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD by Medipart Jerry Alexander — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1989
Date Received
June 13, 1989
Clearance Type
Traditional
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 Medipart Jerry Alexander

  • K896885 — DISPOSABLE RESPIRTORY KIT (MP-200) (February 26, 1990)
  • K896125 — MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M (February 1, 1990)
  • K896475 — DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD (January 22, 1990)
  • K896124 — MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133 (January 22, 1990)
  • K896476 — DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD (January 22, 1990)
  • K893532 — RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963 (August 21, 1989)
  • K862791 — MP-30XM-IE FACE MASK AND FILTER KIT (August 1, 1986)
  • K862785 — MP-1204 DISPOSABLE BACTERIA FILTER (August 1, 1986)
  • K862787 — MP-2831 DISPOSABLE CONDUCTIVE BREATHING FILTER (August 1, 1986)
  • K862788 — MP-4400 MOUTHPIECE-FLANGE SEAL (August 1, 1986)

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