Question 1

Who is the manufacturer of UPGRADED SPIROMETER ST-90?

Accepted Answer

Futuremed Div. of Future Impex Corp. filed the 510(k) submission for UPGRADED SPIROMETER ST-90 (K933511).

Question 2

What is the FDA product code for UPGRADED SPIROMETER ST-90?

Accepted Answer

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

Question 3

When was UPGRADED SPIROMETER ST-90 cleared by the FDA?

Accepted Answer

Feb 10, 1994 (decision: SESE).

Question 4

What is the regulatory pathway for UPGRADED SPIROMETER ST-90?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like UPGRADED SPIROMETER ST-90?

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	K933511
Device Name	UPGRADED SPIROMETER ST-90
Applicant	Futuremed Div. of Future Impex Corp.
Product Code	BTY · Anesthesiology
Decision Date	Feb 10, 1994
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1890
Device Class	Class 2

UPGRADED SPIROMETER ST-90

Device Facts

Regulatory Classification

Identification