Cleared Abbreviated

BABYCARE

K023082 · Bionet Company, Ltd. · Radiology

Mar 2003

Decision

167d

Days

Class 2

Risk

About This 510(k) Submission

K023082 is an FDA 510(k) clearance for the BABYCARE, a Monitor, Blood-flow, Ultrasonic (Class II — Special Controls, product code HEP), submitted by Bionet Company, Ltd. (Alpharetta, US). The FDA issued a Cleared decision on March 3, 2003, 167 days after receiving the submission on September 17, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 884.2660.

Submission Details

510(k) Number	K023082 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 17, 2002
Decision Date	March 03, 2003
Days to Decision	167 days
Submission Type	Abbreviated
Review Panel	Radiology (RA)
Summary	Summary PDF