BABYCARE— 510(k) K023082

Substantially Equivalent

Bionet Company, Ltd.

FDA 510(k) clearance K023082 for BABYCARE, Substantially Equivalent on 2003-03-03. Applicant: Bionet Company, Ltd.. Device class: 2.

Clearance details

Applicant: Bionet Company, Ltd.
Product code: Code HEP
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 2002-09-17
Decision date: 2003-03-03
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HEP

K101960 — SONOTRAX SERIES ULTRASONIC POCKET DOPPLER2010-08-10
K920353 — ULTRACELL INSTRUMENT WIPE1992-09-15
K910462 — POCKET DOP 31991-06-24

More clearances from Bionet Company, Ltd.

K023034 — CARDIOTOUCH-30002002-11-14
K011328 — CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH2001-11-21

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