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510(k) K903694

AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE by Amici, Inc. — Product Code IYT

K903694 is an FDA 510(k) premarket notification submitted by Amici, Inc. for the device "AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE". The FDA issued a decision of Substantially Equivalent on October 3, 1990. The device falls under product code IYT (System, Rebreathing, Radionuclide), a Class II device regulated under 21 CFR 892.1390. Amici, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1990
Date Received
August 15, 1990
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 Amici, Inc.

  • K063716 — AEROSOL SYSTEM (December 28, 2007)
  • K952910 — THE SWIRLER NEBULIZER (March 19, 1997)
  • K952893 — THE SWIRLER AEROSOL SYSTEM (November 3, 1995)
  • K904684 — AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION (January 14, 1991)
  • K903805 — AMICI XENON ADMINISTRATION SET (January 14, 1991)
  • K872920 — AMICI KRYPTON ADMINISTRATION SYSTEM* (February 12, 1988)
  • K865084 — AMICI XENON REBREATHING SYSTEM* (March 3, 1987)

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)
  • K896885 — DISPOSABLE RESPIRTORY KIT (MP-200) (February 26, 1990)

FDA data resources