CHAL-2500— 510(k) K946186

Substantially Equivalent for Some Indications

Hogan & Hartson

FDA 510(k) clearance K946186 for CHAL-2500, Substantially Equivalent for Some Indications on 1995-08-14. Applicant: Hogan & Hartson. Device class: 2.

Clearance details

Applicant: Hogan & Hartson
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 1994-12-20
Decision date: 1995-08-14
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Washington, D.C., DC, 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.