Question 1

Who is the manufacturer of TYPE EXPIRED CO2 9270, CAPNOGRAPH?

Accepted Answer

S & W Medico Teknik filed the 510(k) submission for TYPE EXPIRED CO2 9270, CAPNOGRAPH (K895001).

Question 2

What is the FDA product code for TYPE EXPIRED CO2 9270, CAPNOGRAPH?

Accepted Answer

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

Question 3

When was TYPE EXPIRED CO2 9270, CAPNOGRAPH cleared by the FDA?

Accepted Answer

Feb 22, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for TYPE EXPIRED CO2 9270, CAPNOGRAPH?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like TYPE EXPIRED CO2 9270, CAPNOGRAPH?

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	K895001
Device Name	TYPE EXPIRED CO2 9270, CAPNOGRAPH
Applicant	S & W Medico Teknik
Product Code	CCK · Anesthesiology
Decision Date	Feb 22, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1400
Device Class	Class 2

TYPE EXPIRED CO2 9270, CAPNOGRAPH

Device Facts

Regulatory Classification

Identification