Cleared Traditional

K971601 - OLYMPIC BILI-BASSINET
(FDA 510(k) Clearance)

K971601 · Olympic Medical Corp. · General Hospital

Sep 1997

Decision

146d

Days

Class 2

Risk

K971601 is an FDA 510(k) clearance for the OLYMPIC BILI-BASSINET, a Unit, Neonatal Phototherapy (Class II — Special Controls, product code LBI), submitted by Olympic Medical Corp. (Seattle, US). The FDA issued a Cleared decision on September 24, 1997, 146 days after receiving the submission on May 1, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5700.

Submission Details

510(k) Number	K971601 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 1997
Decision Date	September 24, 1997
Days to Decision	146 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF