Ibc Floguard, Model 6050

by International Biophysics Corp. 510(k)

Active United States

510(k) K992785

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK992785	Date14 Jan 2000Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
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: K992785
FDA Product Code: MJJ

Device Class: Class II
Regulation: 21 CFR Part 870.4400
Advisory Committee: Cardiovascular
FDA Decision: SESE Substantially Equivalent

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