Home / 510(k) Clearances / K853056

510(k) K853056

RESPIR GARD-II FACE MASK CORRUGATED TUBING by Marquest Medical Products, Inc. — Product Code IYT

K853056 is an FDA 510(k) premarket notification submitted by Marquest Medical Products, Inc. for the device "RESPIR GARD-II FACE MASK CORRUGATED TUBING". The FDA issued a decision of Substantially Equivalent on August 7, 1985. The device falls under product code IYT (System, Rebreathing, Radionuclide), a Class II device regulated under 21 CFR 892.1390. Marquest Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1985
Date Received
July 19, 1985
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 Marquest Medical Products, Inc.

  • K050066 — C-CO2 COLORIMETRIC CO2 INDICATOR (March 1, 2005)
  • K970478 — SCT 3000 HEATED HUMIDIFIER (July 16, 1997)
  • K962223 — WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER (January 14, 1997)
  • K962220 — HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER (January 14, 1997)
  • K960972 — DISPOSABLE GAS SAMPLING INTERFACE KITS (October 18, 1996)
  • K961838 — RESPIRGARD II, SPIROGARD (October 18, 1996)
  • K904690 — TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM (February 1, 1991)
  • K903138 — MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM (October 11, 1990)
  • K902632 — GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS (September 4, 1990)
  • K903307 — TEMP MARQ TEMPERATURE TREND INDICATOR (August 17, 1990)

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