SMARTO— 510(k) K163308

Substantially Equivalent

Jeil Medical Corporation

FDA 510(k) clearance K163308 for SMARTO, Substantially Equivalent on 2016-12-27. Applicant: Jeil Medical Corporation. Device class: 1.

Clearance details

Applicant: Jeil Medical Corporation
Product code: Code KIJ
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 2016-11-23
Decision date: 2016-12-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIJ

K112599 — INSURGICAL SINGLE USE POWER EQUIPMENT2012-11-06
K101563 — SMARTO2010-12-17
K972367 — STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT1997-09-04
K970378 — STRYKER 2115 REPLACEMENT BATTERY (2115)1997-04-30
K960711 — ACUMED BONE GRAFT SYSTEM1996-05-07

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