MEDELA SYMPHONY BREAST PUMP, MODEL 024— 510(k) K020518
Substantially EquivalentMedela, Inc.
FDA 510(k) clearance K020518 for MEDELA SYMPHONY BREAST PUMP, MODEL 024, Substantially Equivalent on 2002-03-07. Applicant: Medela, Inc.. Device class: 2.
Clearance details
- Applicant
- Medela, Inc.
- Product code
- Product 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
- Baar, Zug,, CH
Recent devices under product code HGX
view all- K262125 — Nenesupply Venus Handsfree Breast Pump (NBP001-HF)
- K261782 — MODO DUO Electric Pump (B11621, B11673)
- K254203 — Wearable Breast Pump (Model S36)
- 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)
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
- K984589 — PHOTOTHERAPY LAMP
- K983552 — BASIC, MEDIAN, DOMINANT, AND VARIO
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.