Question 1

Who is the manufacturer of LUNG DIFFUSION?

Accepted Answer

Nordan Smith Welding Supplies filed the 510(k) submission for LUNG DIFFUSION (K942864).

Question 2

What is the FDA product code for LUNG DIFFUSION?

Accepted Answer

BZC. It is classified under 21 CFR 868.1880 as a Class 2 device in the Anesthesiology panel.

Question 3

When was LUNG DIFFUSION cleared by the FDA?

Accepted Answer

Mar 3, 1995 (decision: SESE).

Question 4

What is the regulatory pathway for LUNG DIFFUSION?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like LUNG DIFFUSION?

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	K942864
Device Name	LUNG DIFFUSION
Applicant	Nordan Smith Welding Supplies
Product Code	BZC · Anesthesiology
Decision Date	Mar 3, 1995
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1880
Device Class	Class 2

LUNG DIFFUSION

Device Facts

Regulatory Classification

Identification