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510(k) K160274

Hi bebe plus by Bistos Co., Ltd. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2016
Date Received
February 2, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type

Other clearances by Bistos Co., Ltd.

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  • K142799 — Model BT-220L and BT-220C (July 9, 2015)
  • K132543 — INFANT INCUBATOR (July 3, 2014)
  • K121267 — BT-200V VASCULAR DOPPLER (August 2, 2012)
  • K103545 — BT-350 (May 13, 2011)
  • K100885 — FETAL MONITOR MODEL: BT-200T (June 7, 2010)
  • K052190 — FETAL MONITOR, MODELS BT-300 AND BT-200 (October 4, 2005)

Other clearances for product code HGX

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  • K253072 — Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 P (December 23, 2025)
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