ELPHA 2000— 510(k) K914231

Substantially Equivalent

Biometer Intl. A/S

FDA 510(k) clearance K914231 for ELPHA 2000, Substantially Equivalent on 1992-05-28. Applicant: Biometer Intl. A/S. Device class: 2.

Clearance details

Applicant: Biometer Intl. A/S
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 1991-09-20
Decision date: 1992-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

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More clearances from Biometer Intl. A/S

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K881196 — AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL1989-06-16

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