EUROTROL GAS - ISE CONTROL— 510(k) K955340

Substantially Equivalent

Direct Solutions

FDA 510(k) clearance K955340 for EUROTROL GAS - ISE CONTROL, Substantially Equivalent on 1995-12-26. Applicant: Direct Solutions. Device class: 1.

Clearance details

Applicant: Direct Solutions
Product code: Code JJS
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1995-11-20
Decision date: 1995-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westford, MA, US

Download summary PDF View on FDA.gov ↗

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