INSIGHT DISCOVERY— 510(k) K063447

Substantially Equivalent

Fasstech

FDA 510(k) clearance K063447 for INSIGHT DISCOVERY, Substantially Equivalent on 2007-08-16. Applicant: Fasstech. Device class: 2.

Clearance details

Applicant: Fasstech
Product code: Code IKN
Device class: Class 2
Regulation: 21 CFR 890.1375
Advisory panel: Physical Medicine
Date received: 2006-11-15
Decision date: 2007-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Billerica, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IKN

K172743 — Natus VikingQuest2017-12-19
K163150 — ViMove22017-07-14
K162383 — Cadwell Sierra Summit, Cadwell Sierra Ascent2017-03-01
K142494 — ViMove2015-05-28
K131094 — VIMOVE2014-07-11

More clearances from Fasstech

K033452 — CWAS 10002003-11-28
K023209 — INSIGHT MILLENNIUM III2003-10-10
K011964 — INSIGHT MILLENNIUM PLUS2001-09-20
K011983 — INSIGHT GENESIS2001-08-30
K990778 — INSIGHT MILLENNIUM1999-06-03

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