Ibc Vrv, Model 1350

by International Biophysics Corp. 510(k)

Active United States

510(k) K992657

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK992657	Date18 Feb 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Withdrawn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 11 Oct 2026.

Specification

510(k)

510(k) Number: K992657
FDA Product Code: DWD

Device Class: Class II
Regulation: 21 CFR Part 870.4430
Advisory Committee: Cardiovascular
FDA Decision: SESE Substantially Equivalent

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