BEDSIDE BUTLER— 510(k) K944345

Substantially Equivalent

Trac Medical, Inc.

FDA 510(k) clearance K944345 for BEDSIDE BUTLER, Substantially Equivalent on 1994-10-17. Applicant: Trac Medical, Inc.. Device class: 2.

Clearance details

Applicant: Trac Medical, Inc.
Product code: Code IQA
Device class: Class 2
Regulation: 21 CFR 890.3725
Advisory panel: Physical Medicine
Date received: 1994-09-06
Decision date: 1994-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raliegh, NC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Trac Medical, Inc.

K933431 — ORTHOTRAC COAXIAL LASER1993-10-05

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