PORTAREM 2000— 510(k) K943460

Substantially Equivalent

Starkey Laboratories, Inc.

FDA 510(k) clearance K943460 for PORTAREM 2000, Substantially Equivalent on 1994-10-21. Applicant: Starkey Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Starkey Laboratories, Inc.
Product code: Code ETW
Device class: Class 2
Regulation: 21 CFR 874.3310
Advisory panel: Ear, Nose, Throat
Date received: 1994-07-18
Decision date: 1994-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

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