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510(k) K913416

TETLEY PATIENT ADMINISTRATION SET by Tetley Medical , Ltd. — Product Code IYT

K913416 is an FDA 510(k) premarket notification submitted by Tetley Medical , Ltd. for the device "TETLEY PATIENT ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on October 28, 1991. 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
October 28, 1991
Date Received
July 31, 1991
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

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  • K952223 — XENON GAS BREATHING CIRCUIT (August 11, 1995)
  • K914747 — XENON CIRCUIT (February 27, 1992)
  • 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