Question 1

Who is the manufacturer of OXYGEN CONCENTRATOR?

Accepted Answer

C.R. Bard, Inc. filed the 510(k) submission for OXYGEN CONCENTRATOR (K823524).

Question 2

What is the FDA product code for OXYGEN CONCENTRATOR?

Accepted Answer

CAW. It is classified under 21 CFR 868.5440 as a Class 2 device in the Anesthesiology panel.

Question 3

When was OXYGEN CONCENTRATOR cleared by the FDA?

Accepted Answer

Dec 28, 1982 (decision: SESE).

Question 4

What is the regulatory pathway for OXYGEN CONCENTRATOR?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like OXYGEN CONCENTRATOR?

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	K823524
Device Name	OXYGEN CONCENTRATOR
Applicant	C.R. Bard, Inc.
Product Code	CAW · Anesthesiology
Decision Date	Dec 28, 1982
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5440
Device Class	Class 2

OXYGEN CONCENTRATOR

Device Facts

Regulatory Classification

Identification