HYDROCHECK MICRO FILTER— 510(k) K970488
Substantially EquivalentWhite River Concepts
FDA 510(k) clearance K970488 for HYDROCHECK MICRO FILTER, Substantially Equivalent on 1997-11-04. Applicant: White River Concepts. Device class: 2.
Clearance details
- Applicant
- White River Concepts
- Product code
- Code HGX
- Device class
- Class 2
- Regulation
- 21 CFR 884.5160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Clemente, CA, US
Recent devices under product code HGX
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- K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))
- K260259 — DiscreetDuo Flow Wearable Breast Pump (Model S3)
More clearances from White River Concepts
view allAdverse 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.