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510(k) K023082

BABYCARE by Bionet Company, Ltd. — Product Code HEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2003
Date Received
September 17, 2002
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Blood-Flow, Ultrasonic
Device Class
Class II
Regulation Number
884.2660
Review Panel
OB
Submission Type

Other clearances by Bionet Company, Ltd.

  • K023034 — CARDIOTOUCH-3000 (November 14, 2002)
  • K011328 — CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH (November 21, 2001)

Other clearances for product code HEP

  • K101960 — SONOTRAX SERIES ULTRASONIC POCKET DOPPLER (August 10, 2010)
  • K920353 — ULTRACELL INSTRUMENT WIPE (September 15, 1992)
  • K910462 — POCKET DOP 3 (June 24, 1991)