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510(k) K080657

NEB-90 LARGE VOLUME MEDICATION NEBULIZER by Medi Nuclear Corp., Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2008
Date Received
March 7, 2008
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 Medi Nuclear Corp., Inc.

  • K082541 — HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM (November 26, 2008)
  • K080969 — HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 (July 25, 2008)
  • K915075 — NEBULIZER (DIRECT PATIENT INTERFACE) (July 16, 1992)
  • K865107 — AERO-VENT AEROSOL UNIT (October 20, 1987)
  • K865093 — SAFE-T-SHIELD MOUTHPIECE (January 15, 1987)
  • K863996 — MODEL XE-103 XENON/MASTER II (November 4, 1986)
  • K813379 — RADIONUCLIDE DOSE CALIBRATOR (January 22, 1982)
  • K810819 — MEDI/NUCLEAR #XE-102 XENON/MASTER (April 14, 1981)

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