BIO-COORDINATOR SYSTEM— 510(k) K895398

Substantially Equivalent

Bio-Harmonizer, Inc.

FDA 510(k) clearance K895398 for BIO-COORDINATOR SYSTEM, Substantially Equivalent on 1989-09-28. Applicant: Bio-Harmonizer, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Harmonizer, Inc.
Product code: Code IKK
Device class: Class 2
Regulation: 21 CFR 890.1925
Advisory panel: Physical Medicine
Date received: 1989-09-07
Decision date: 1989-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington D.C., 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.