Spirovision

by Futuremed Div. of Future Impex Corp. 510(k)

Active United States

510(k) K864885

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK864885	Date15 Jan 1987Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 10 Oct 2026.

Specification

510(k)

510(k) Number: K864885
FDA Product Code: BZM

Device Class: Class II
Regulation: 21 CFR Part 868.1900
Advisory Committee: Anesthesiology
FDA Decision: SESE Substantially Equivalent

Other devices from Futuremed Div. of Future Impex Corp.

Carbon Electrode

Class II
Selector Sl 01

Class II
Conductivity Gel

Class II
Tens Device for Relief of Chronic Pain

Class II
St-460 Spiro Analyzer Spirometer

Class II
Audiometer Da 323

Class II

See all devices from Futuremed Div. of Future Impex Corp. →