Question 1

Who is the manufacturer of O.1 T0 40.0% CARBON DIOX. O.1 TO 90.0% OXY. U.S.P?

Accepted Answer

Matheson Gas Products, Inc. filed the 510(k) submission for O.1 T0 40.0% CARBON DIOX. O.1 TO 90.0% OXY. U.S.P (K871103).

Question 2

What is the FDA product code for O.1 T0 40.0% CARBON DIOX. O.1 TO 90.0% OXY. U.S.P?

Accepted Answer

BXK. It is classified under 21 CFR 868.6400 as a Class 1 device in the Anesthesiology panel.

Question 3

When was O.1 T0 40.0% CARBON DIOX. O.1 TO 90.0% OXY. U.S.P cleared by the FDA?

Accepted Answer

Apr 20, 1987 (decision: SESE).

Question 4

What is the regulatory pathway for O.1 T0 40.0% CARBON DIOX. O.1 TO 90.0% OXY. U.S.P?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like O.1 T0 40.0% CARBON DIOX. O.1 TO 90.0% OXY. U.S.P?

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	K871103
Device Name	O.1 T0 40.0% CARBON DIOX. O.1 TO 90.0% OXY. U.S.P
Applicant	Matheson Gas Products, Inc.
Product Code	BXK · Anesthesiology
Decision Date	Apr 20, 1987
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.6400
Device Class	Class 1

O.1 T0 40.0% CARBON DIOX. O.1 TO 90.0% OXY. U.S.P

Device Facts

Regulatory Classification

Identification