K-number	K251512
Device name	Hi bebe super (BT-150B)
Applicant	Bistos Co., Ltd.
Product code	HGX
Device class	Class II
Decision date	Sep 25, 2025
Decision	Substantially Equivalent
Regulation	884.5160

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Hi bebe super (BT-150B) is a powered breast pump intended for single-user lactating women to express and collect breast milk. It is an over-the-counter device regulated as a Class II medical device under 21 CFR 884.5160.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Hi bebe super (BT-150B)

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