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510(k) K210992

Altech® Exhalation Valve (Single Limb and Dual Limb) by Meditera Tibbi Malzeme San VE Tic AS — Product Code CBP

K210992 is an FDA 510(k) premarket notification submitted by Meditera Tibbi Malzeme San VE Tic AS for the device "Altech® Exhalation Valve (Single Limb and Dual Limb)". The FDA issued a decision of Substantially Equivalent on December 23, 2021. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870. Meditera Tibbi Malzeme San VE Tic AS has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2021
Date Received
April 2, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Non-Rebreathing
Device Class
Class II
Regulation Number
868.5870
Review Panel
AN
Submission Type

Other clearances by Meditera Tibbi Malzeme San VE Tic AS

  • K192713 — Altera Filter and HME/Filter (March 16, 2020)
  • K192563 — Altera gas Sampling Lines (January 17, 2020)

Other clearances for product code CBP

  • K241366 — QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MT (October 29, 2024)
  • K234053 — F&P Optiflow Flow Diverter (August 9, 2024)
  • K192285 — CPR Face Shield (November 25, 2020)
  • K173770 — OJR215 Pressure Relief Manifold (April 5, 2019)
  • K171961 — Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compo (November 17, 2017)
  • K152521 — Seal Rite Non-Rebreathing Valve (June 3, 2016)
  • K142764 — KYOLING CPR Mask with Oxygen Port and Without Oxygen Port (July 9, 2015)
  • K142402 — BigEasy Non-Rebreathing Valve (March 23, 2015)
  • K132143 — EXHALATION VALVE (June 4, 2014)
  • K112126 — GENUINE FIRST AID CPR MASK (December 1, 2011)

FDA data resources