Question 1

Who is the manufacturer of MGA-IR SIDESTREAM PCO2 MODULE?

Accepted Answer

Marquette Gas Analysis Corp. filed the 510(k) submission for MGA-IR SIDESTREAM PCO2 MODULE (K904863).

Question 2

What is the FDA product code for MGA-IR SIDESTREAM PCO2 MODULE?

Accepted Answer

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

Question 3

When was MGA-IR SIDESTREAM PCO2 MODULE cleared by the FDA?

Accepted Answer

Jun 19, 1991 (decision: SESE).

Question 4

What is the regulatory pathway for MGA-IR SIDESTREAM PCO2 MODULE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like MGA-IR SIDESTREAM PCO2 MODULE?

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	K904863
Device Name	MGA-IR SIDESTREAM PCO2 MODULE
Applicant	Marquette Gas Analysis Corp.
Product Code	CCK · Anesthesiology
Decision Date	Jun 19, 1991
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1400
Device Class	Class 2

MGA-IR SIDESTREAM PCO2 MODULE

Device Facts

Regulatory Classification

Identification