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510(k) K896124

MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133 by Medipart Jerry Alexander — Product Code IYT

K896124 is an FDA 510(k) premarket notification submitted by Medipart Jerry Alexander for the device "MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133". The FDA issued a decision of Substantially Equivalent on January 22, 1990. The device falls under product code IYT (System, Rebreathing, Radionuclide), a Class II device regulated under 21 CFR 892.1390. Medipart Jerry Alexander has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1990
Date Received
October 23, 1989
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 Medipart Jerry Alexander

  • K896885 — DISPOSABLE RESPIRTORY KIT (MP-200) (February 26, 1990)
  • K896125 — MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M (February 1, 1990)
  • K896476 — DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD (January 22, 1990)
  • K896475 — DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD (January 22, 1990)
  • K894138 — MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD (September 26, 1989)
  • K893532 — RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963 (August 21, 1989)
  • K862785 — MP-1204 DISPOSABLE BACTERIA FILTER (August 1, 1986)
  • K862794 — MP-070 RADIOAEROSOL KIT (August 1, 1986)
  • K862795 — MP-070-M RADIOAEROSOL KIT (August 1, 1986)
  • K862783 — MP-XMV DISPOSABLE FACE MASK (August 1, 1986)

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)
  • K903805 — AMICI XENON ADMINISTRATION SET (January 14, 1991)
  • K904684 — AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION (January 14, 1991)
  • K903694 — AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE (October 3, 1990)

FDA data resources