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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 Jun 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 8 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 2, 1981
Date Received
Apr 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
510(k)

Other clearances by Medi-Physics Inc. Dba Nycomed Amersham Imaging

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

Other clearances for product code IYT

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

FDA data resources

Source: FDA 510(k) database entry for K811118. Report a data issue: hello@regdatalab.com.