ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101— 510(k) K052047
Substantially EquivalentAvent America, Inc.
FDA 510(k) clearance K052047 for ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101, Substantially Equivalent on 2005-09-22. Applicant: Avent America, Inc.. Device class: 2.
Clearance details
- Applicant
- Avent America, Inc.
- 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
- Framingham, MA, US
Recent devices under product code HGX
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- K260643 — Cimilre Dual Max
- 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 Avent America, Inc.
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.