Question 1

Who is the manufacturer of SPIROMETRICS 2453 & SMI III?

Accepted Answer

Spirometrics, Inc. filed the 510(k) submission for SPIROMETRICS 2453 & SMI III (K850045).

Question 2

What is the FDA product code for SPIROMETRICS 2453 & SMI III?

Accepted Answer

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

Question 3

When was SPIROMETRICS 2453 & SMI III cleared by the FDA?

Accepted Answer

Feb 14, 1985 (decision: SESE).

Question 4

What is the regulatory pathway for SPIROMETRICS 2453 & SMI III?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like SPIROMETRICS 2453 & SMI III?

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	K850045
Device Name	SPIROMETRICS 2453 & SMI III
Applicant	Spirometrics, Inc.
Product Code	BTY · Anesthesiology
Decision Date	Feb 14, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1890
Device Class	Class 2

SPIROMETRICS 2453 & SMI III

Device Facts

Regulatory Classification

Identification