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510(k) K200916

Patient Administration Set by Cyclomedica Australia Pty, Ltd. — Product Code IYT

K200916 is an FDA 510(k) premarket notification submitted by Cyclomedica Australia Pty, Ltd. for the device "Patient Administration Set". The FDA issued a decision of Substantially Equivalent on September 1, 2020. The device falls under product code IYT (System, Rebreathing, Radionuclide), a Class II device regulated under 21 CFR 892.1390.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2020
Date Received
April 6, 2020
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 for product code IYT

  • K253942 — Pulmonex II Xenon System (132-503) (July 7, 2026)
  • 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)
  • K896885 — DISPOSABLE RESPIRTORY KIT (MP-200) (February 26, 1990)

FDA data resources