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510(k) K811118

KRYPTON MASKS & TUBING by Medi-Physics Inc. Dba Nycomed Amersham Imaging — Product Code IYT

K811118 is an FDA 510(k) premarket notification submitted by Medi-Physics Inc. Dba Nycomed Amersham Imaging for the device "KRYPTON MASKS & TUBING". The FDA issued a decision of Substantially Equivalent on June 2, 1981. The device falls under product code IYT (System, Rebreathing, Radionuclide), a Class II device regulated under 21 CFR 892.1390. Medi-Physics Inc. Dba Nycomed Amersham Imaging has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1981
Date Received
April 24, 1981
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-Physics Inc. Dba Nycomed Amersham Imaging

  • K010821 — ECHOSEED/IODINE-125 SEEDS, MODEL 6733 (April 11, 2001)
  • K940632 — I-125 RAPID STRAND (September 2, 1994)
  • K921961 — SDMO APPLICATOR CODE: ASN.8236 (July 1, 1992)
  • K915156 — I-125 SEEDS CODE: 6702 (January 6, 1992)
  • K914268 — I-125 SEEDS IN CARRIER, CODE: 6720 (November 22, 1991)
  • K914281 — I-125 SEEDS, CODE: 6711 (November 22, 1991)
  • K811688 — TUNGSTEN SYRINGE SHIELD (July 2, 1981)
  • K811677 — KRYPTON CART (July 2, 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