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510(k) K082541

HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM by Medi Nuclear Corp., Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2008
Date Received
September 2, 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.

  • K080969 — HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 (July 25, 2008)
  • K080657 — NEB-90 LARGE VOLUME MEDICATION NEBULIZER (June 30, 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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