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510(k) K952223

XENON GAS BREATHING CIRCUIT by Intertech Resources, Inc. — Product Code IYT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1995
Date Received
May 12, 1995
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 Intertech Resources, Inc.

  • K961318 — 1ST RESPONSE DISPOSABLE MANOMETER (December 17, 1996)
  • K955008 — HEAT & MOISTURE EXCHANGER (January 30, 1996)
  • K953580 — HEAT MOISTURE EXCHANGER (September 15, 1995)
  • K952169 — SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC (June 8, 1995)
  • K952062 — PFT FILTER (June 8, 1995)
  • K952214 — SIMS INTERTECH HYPERINFLATION BAG SYSTEM (June 8, 1995)
  • K935036 — HEPA FILTERED HEAT AND MOISTURE EXCHANGER (January 25, 1994)
  • K930816 — HEPA FILTERED HME (July 1, 1993)
  • K922479 — DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED (October 30, 1992)
  • K921624 — DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS (June 30, 1992)

Other clearances for product code IYT

  • K200916 — Patient Administration Set (September 1, 2020)
  • K953513 — XENON CIRCUIT (November 3, 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)
  • K896885 — DISPOSABLE RESPIRTORY KIT (MP-200) (February 26, 1990)
  • K896125 — MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M (February 1, 1990)