FDA 510(k) clearance · back to tracker

DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT

Life-Tech Intl., Inc. cleared K923071 on 1992-09-28, decision: substantially equivalent

K-number

K923071

Sponsor

Life-Tech Intl., Inc.

Device

DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT

Class

Class I

Decision

Substantially Equivalent

Decision date

1992-09-28

Product code

ESD

Advisory committee

Ear, Nose, Throat

Medical specialty

Ear, Nose, Throat

Regulation number

874.3300

Official FDA record

Open K923071on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K923071 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.