MEDELA BATTERY OPERATED BREAST PUMP— 510(k) K901344
Substantially EquivalentMedela, Inc.
FDA 510(k) clearance K901344 for MEDELA BATTERY OPERATED BREAST PUMP, Substantially Equivalent on 1990-08-06. Applicant: Medela, Inc.. Device class: 2.
Clearance details
- Applicant
- Medela, 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
- Chicago, IL, US
Recent devices under product code HGX
view all- K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) +1 more
- K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF)
- 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 Medela, Inc.
view all- K161811 — Medela Low Dose Enteral Syringe
- K161725 — Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail
- K031614 — MEDELA PUMP IN STYLE ADVANCED BREAST PUMP
- K020518 — MEDELA SYMPHONY BREAST PUMP, MODEL 024
- K984589 — PHOTOTHERAPY LAMP
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.