Question 1

Who is the manufacturer of DSXL DIFFUSION SPIROMETER?

Accepted Answer

Inair , Ltd. filed the 510(k) submission for DSXL DIFFUSION SPIROMETER (K961252).

Question 2

What is the FDA product code for DSXL DIFFUSION SPIROMETER?

Accepted Answer

BTY. It is classified under 21 CFR 868.1890 as a Class 2 device in the Anesthesiology panel.

Question 3

When was DSXL DIFFUSION SPIROMETER cleared by the FDA?

Accepted Answer

Feb 14, 1997 (decision: SESE).

Question 4

What is the regulatory pathway for DSXL DIFFUSION SPIROMETER?

Accepted Answer

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

Question 5

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

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	K961252
Device Name	DSXL DIFFUSION SPIROMETER
Applicant	Inair , Ltd.
Product Code	BTY · Anesthesiology
Decision Date	Feb 14, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1890
Device Class	Class 2

DSXL DIFFUSION SPIROMETER

Device Facts

Regulatory Classification

Identification