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510(k) K200675

Hi bebe super (Models BT-150S and BT-150L) by Bistos Co., Ltd. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2021
Date Received
March 16, 2020
Clearance Type
Special
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.

  • K251512 — Hi bebe super (BT-150B) (September 25, 2025)
  • K232991 — BT-1000 (August 28, 2024)
  • K210289 — Infant Phototherapy Equipment (May 28, 2021)
  • K160274 — Hi bebe plus (September 1, 2016)
  • 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)

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  • K252754 — Wearable Electric Breast Pump (YM-8803) (December 19, 2025)
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