WATER DRIVEN BREAST PUMP BY BABY NURSE— 510(k) K853326

Substantially Equivalent

Baby Nurse

FDA 510(k) clearance K853326 for WATER DRIVEN BREAST PUMP BY BABY NURSE, Substantially Equivalent on 1985-11-19. Applicant: Baby Nurse.

Clearance details

Applicant
Baby Nurse
Product code
Code HGX
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Phoenix, AZ, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HGX

product code HGX
Injury
758
Other
2
Total
760

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.