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510(k) K863996

MODEL XE-103 XENON/MASTER II by Medi Nuclear Corp., Inc. — Product Code IYT

K863996 is an FDA 510(k) premarket notification submitted by Medi Nuclear Corp., Inc. for the device "MODEL XE-103 XENON/MASTER II". The FDA issued a decision of Substantially Equivalent on November 4, 1986. The device falls under product code IYT (System, Rebreathing, Radionuclide), a Class II device regulated under 21 CFR 892.1390. Medi Nuclear Corp., Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1986
Date Received
October 14, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Rebreathing, Radionuclide
Device Class
Class II
Regulation Number
892.1390
Review Panel
RA
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)
  • 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)
  • K813379 — RADIONUCLIDE DOSE CALIBRATOR (January 22, 1982)
  • K810819 — MEDI/NUCLEAR #XE-102 XENON/MASTER (April 14, 1981)

Other clearances for product code IYT

  • K253942 — Pulmonex II Xenon System (132-503) (July 7, 2026)
  • K200916 — Patient Administration Set (September 1, 2020)
  • K953513 — XENON CIRCUIT (November 3, 1995)
  • K952223 — XENON GAS BREATHING CIRCUIT (August 11, 1995)
  • K914747 — XENON CIRCUIT (February 27, 1992)
  • K913416 — TETLEY PATIENT ADMINISTRATION SET (October 28, 1991)
  • K912626 — BOLUS XENON CIRCUIT (August 2, 1991)
  • K904684 — AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION (January 14, 1991)
  • K903805 — AMICI XENON ADMINISTRATION SET (January 14, 1991)
  • K903694 — AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE (October 3, 1990)

FDA data resources