BACKCYCLER CPM(TM)— 510(k) K945690

Substantially Equivalent

Ergomedics, Inc.

FDA 510(k) clearance K945690 for BACKCYCLER CPM(TM), Substantially Equivalent on 1995-06-22. Applicant: Ergomedics, Inc.. Device class: 1.

Clearance details

Applicant: Ergomedics, Inc.
Product code: Code BXB
Device class: Class 1
Regulation: 21 CFR 890.5380
Advisory panel: Physical Medicine
Date received: 1994-11-21
Decision date: 1995-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, 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.