HA-2000 REAL EAR SPECTROSCOPE— 510(k) K862026

Substantially Equivalent

And/Or Corp.

FDA 510(k) clearance K862026 for HA-2000 REAL EAR SPECTROSCOPE, Substantially Equivalent on 1986-08-15. Applicant: And/Or Corp.. Device class: 2.

Clearance details

Applicant: And/Or Corp.
Product code: Code ETW
Device class: Class 2
Regulation: 21 CFR 874.3310
Advisory panel: Ear, Nose, Throat
Date received: 1986-05-28
Decision date: 1986-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, 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.