DISPOSABLE TRANSDUCER MANIFOLD— 510(k) K890676

Clearance details

Applicant

L.O.N. Research, Inc.

Product code

Code DTL

Device class

Class 2

Regulation

21 CFR 870.4290

Advisory panel

Cardiovascular

Date received

1989-02-09

Decision date

1989-07-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Sanford, FL, US

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Malfunction

770

Total

770

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →