PADNET 2.0— 510(k) K122281

Substantially Equivalent

Biomedix, Inc.

FDA 510(k) clearance K122281 for PADNET 2.0, Substantially Equivalent on 2012-08-29. Applicant: Biomedix, Inc.. Device class: 2.

Clearance details

Applicant: Biomedix, Inc.
Product code: Code JOM
Device class: Class 2
Regulation: 21 CFR 870.2780
Advisory panel: Cardiovascular
Date received: 2012-07-30
Decision date: 2012-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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 Biomedix, Inc.

K142097 — SELEC-3 I.V.ADMINISTRATION SET2014-08-29
K073146 — PADNET+2007-11-21
K050182 — Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM2005-08-09
K042616 — BIOMEDIX PADNET LAB2004-10-12
K033627 — Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM2004-05-21

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