Altera gas Sampling Lines

FDA 510(k) K192563 · Meditera Tibbi Malzeme San VE Tic AS

Substantially Equivalent

510(k) numberK192563

Submission

Device name
Altera gas Sampling Lines
Applicant
Meditera Tibbi Malzeme San VE Tic AS
Izmir, TR
Received
September 17, 2019
Decision date
January 17, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1400
Specialty
Anesthesiology

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Questions and answers

When was Altera gas Sampling Lines cleared by the FDA?

Altera gas Sampling Lines (K192563) received a 510(k) decision of Substantially Equivalent on January 17, 2020, 122 days after the submission was received.

What is the product code of K192563?

The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.