BODYTRONIC 200— 510(k) K123921

Substantially Equivalent

Bauerfeind AG

FDA 510(k) clearance K123921 for BODYTRONIC 200, Substantially Equivalent on 2013-04-26. Applicant: Bauerfeind AG. Device class: 2.

Clearance details

Applicant: Bauerfeind AG
Product code: Code JOM
Device class: Class 2
Regulation: 21 CFR 870.2780
Advisory panel: Cardiovascular
Date received: 2012-12-20
Decision date: 2013-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zeulenroda-Triebes, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code JOM

K220527 — PADnet Xpress2022-10-20
K213730 — MESI mTABLET TBI diagnostic system, MESI mTABLET TBI2022-04-21
K200567 — ASI Plethysmogrpah Analyzer2021-02-26
K201046 — Automated ankle brachial pressure index measuring device, MESI mTABLET system2020-12-11
K191266 — VitalScan ANS2020-01-15

More clearances from Bauerfeind AG

K111662 — VENOTRAIN CURAFLOW2011-10-04

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