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510(k) K912626

BOLUS XENON CIRCUIT by Vital Signs, Inc. — Product Code IYT

K912626 is an FDA 510(k) premarket notification submitted by Vital Signs, Inc. for the device "BOLUS XENON CIRCUIT". The FDA issued a decision of Substantially Equivalent on August 2, 1991. The device falls under product code IYT (System, Rebreathing, Radionuclide), a Class II device regulated under 21 CFR 892.1390. Vital Signs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1991
Date Received
June 13, 1991
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 Vital Signs, Inc.

  • K112902 — ENFLOW IV FLUID WARMER (March 14, 2012)
  • K041309 — IMASK TM (June 30, 2004)
  • K030985 — BREAS PV 10I CPAP SYSTEM, MODEL PV 10I (October 15, 2003)
  • K022402 — DISPOSABLE PRESSURE MANOMETER (August 22, 2002)
  • K021315 — SURE-LOK (August 21, 2002)
  • K002454 — BREAS HA50 HUMIDIFIER, MODEL HA50 (March 7, 2001)
  • K001553 — BREAS PV 100 CPAP SYSTEM (August 3, 2000)
  • K000441 — BODYGUARD (April 11, 2000)
  • K994044 — CLEEN-ABLE (February 25, 2000)
  • K990412 — CUFF-ABLE PLUS (September 1, 1999)

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

FDA data resources