K-number	K251450
Device name	Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009)
Applicant	Shenzhen Desida Technology Co., Ltd.
Product code	BTA
Device class	Class II
Decision date	Jun 6, 2025
Decision	Substantially Equivalent
Regulation	878.4780

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Baby Nasal Aspirator (models BN002, BN006, BN007, BN008, BN009) is a powered suction pump device intended for intermittent removal of nasal secretions and mucus from children ages 2-12 years in a home environment. It is classified as a Class II medical device under 21 CFR 878.4780.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

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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Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009)

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