Question 1

Who is the manufacturer of ST-460 SPIRO ANALYZER SPIROMETER?

Accepted Answer

Futuremed Div. of Future Impex Corp. filed the 510(k) submission for ST-460 SPIRO ANALYZER SPIROMETER (K852308).

Question 2

What is the FDA product code for ST-460 SPIRO ANALYZER SPIROMETER?

Accepted Answer

BZG. It is classified under 21 CFR 868.1840 as a Class 2 device in the Anesthesiology panel.

Question 3

When was ST-460 SPIRO ANALYZER SPIROMETER cleared by the FDA?

Accepted Answer

Jun 24, 1985 (decision: SESE).

Question 4

What is the regulatory pathway for ST-460 SPIRO ANALYZER SPIROMETER?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like ST-460 SPIRO ANALYZER 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	K852308
Device Name	ST-460 SPIRO ANALYZER SPIROMETER
Applicant	Futuremed Div. of Future Impex Corp.
Product Code	BZG · Anesthesiology
Decision Date	Jun 24, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1840
Device Class	Class 2

ST-460 SPIRO ANALYZER SPIROMETER

Device Facts

Regulatory Classification

Identification