Cleared Special

K081399 - AVIATOR TRANSPORT INCUBATOR
(FDA 510(k) Clearance)

K081399 · International Biomedical, Ltd. · General Hospital

Jun 2008

Decision

18d

Days

Class 2

Risk

K081399 is an FDA 510(k) clearance for the AVIATOR TRANSPORT INCUBATOR, a Incubator, Neonatal Transport (Class II — Special Controls, product code FPL), submitted by International Biomedical, Ltd. (Austin, US). The FDA issued a Cleared decision on June 6, 2008, 18 days after receiving the submission on May 19, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5410.

Submission Details

510(k) Number	K081399 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 19, 2008
Decision Date	June 06, 2008
Days to Decision	18 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Statement