BARTRONIX IN-BED ACTIVITY MONITOR— 510(k) K914859

Substantially Equivalent

Bartronix

FDA 510(k) clearance K914859 for BARTRONIX IN-BED ACTIVITY MONITOR, Substantially Equivalent on 1992-04-13. Applicant: Bartronix. Device class: 1.

Clearance details

Applicant: Bartronix
Product code: Code KMI
Device class: Class 1
Regulation: 21 CFR 880.2400
Advisory panel: General Hospital
Date received: 1991-10-29
Decision date: 1992-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KMI

K141877 — LEAF PATIENT MONITORING SYSTEM2014-11-10
K131585 — INTEL-GE CARE INNOVATIONS QUIETCARE2013-10-08
K130752 — DYNASENSE SYSTEM2013-08-15
K101109 — VIVATRAK2010-07-15
K090138 — MOBILECARE MONITOR, MODEL 21002009-04-24

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