Question 1

Who is the manufacturer of MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE?

Accepted Answer

Oridion Medical 1987 , Ltd. filed the 510(k) submission for MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE (K011536).

Question 2

What is the FDA product code for MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE?

Accepted Answer

CCK. It is classified under 21 CFR 868.1400 as a Class 2 device in the Anesthesiology panel.

Question 3

When was MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE cleared by the FDA?

Accepted Answer

Nov 14, 2001 (decision: SESE).

Question 4

What is the regulatory pathway for MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE?

Accepted Answer

510(k) clearance (submission type: Special).

Question 5

Who can help prepare an FDA 510(k) submission like MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K011536
Device Name	MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE
Applicant	Oridion Medical 1987 , Ltd.
Product Code	CCK · Anesthesiology
Decision Date	Nov 14, 2001
Decision	SESE
Submission Type	Special
Regulation	21 CFR 868.1400
Device Class	Class 2

MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE

Device Facts

Regulatory Classification

Identification