B-1000— 510(k) K844226

Substantially Equivalent

Biotrine Corp.

FDA 510(k) clearance K844226 for B-1000, Substantially Equivalent on 1984-11-20. Applicant: Biotrine Corp.. Device class: 2.

Clearance details

Applicant: Biotrine Corp.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 1984-11-01
Decision date: 1984-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, 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.