HEARING AIDS HB-36M, HB-36MS, HB-36MT, HI-67P, EXCEL-1000— 510(k) K935559

Name: FDA 510(k) clearance K935559
Creator: U.S. Food and Drug Administration
Published: 1994-01-27

Substantially Equivalent

Rockwin Corp.

FDA 510(k) clearance K935559 for HEARING AIDS HB-36M, HB-36MS, HB-36MT, HI-67P, EXCEL-1000, Substantially Equivalent on 1994-01-27. Applicant: Rockwin Corp.. Device class: 1.

Clearance details

Applicant: Rockwin Corp.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1993-11-17
Decision date: 1994-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dekalb, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.