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510(k) K892520

BREATHING CIRCUIT BACTERIAL FILTERS by Arbo Medical, Inc. — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1989
Date Received
April 11, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type

Other clearances by Arbo Medical, Inc.

  • K940323 — ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & (April 12, 1995)
  • K935437 — ARBO H85V/H87V/H27V DISPOS MONIT ELECTRODES (April 6, 1995)
  • K942905 — DISPOSABLE TEMPERATURE PROBE COVER (February 27, 1995)
  • K940302 — ARBO MONITRING SAFETY CABLE & LEAD WIRE SYSTEMS/ARBO UNSHEILDED SAFETY CABLE & L (November 30, 1994)
  • K940322 — ARBO VS MONITOR CABLE & LEADWIRE SYSTEM ARBO SHIELDED SAFETY CABLE & LEAD WIRE (November 28, 1994)
  • K935246 — ARBO H49P, H59P DISPOSABLE MONITORING ELECTRODES (November 16, 1994)
  • K935429 — ARBO H90, H91, H135 DISPOSABLE MONITORING ELECTRODES (November 1, 1994)
  • K935281 — ARBO H87P, H85P, H27P DISPOSABLE MONITORING ELECTRODES (September 6, 1994)
  • K905545 — ULTRASOUND TRANSMISSION GEL (March 29, 1991)
  • K902788 — CLEM TM (September 12, 1990)

Other clearances for product code CAH

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  • K223258 — TNI Clear-Guard™ 3 angled breathing filter (1545020) (June 15, 2023)
  • K221472 — Filter and HME/Filter (February 8, 2023)
  • K221836 — Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus (December 7, 2022)
  • K221250 — EasyOne Filter (November 22, 2022)
  • K210352 — GGM Breathing Circuit Bacterial Filter (March 27, 2022)
  • K211286 — Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger (November 16, 2021)
  • K202459 — Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-H (September 26, 2021)