IVEX MODEL NO. BP 3000 BREASTPUMP— 510(k) K893545
Substantially EquivalentIvex Medical, Inc.
FDA 510(k) clearance K893545 for IVEX MODEL NO. BP 3000 BREASTPUMP, Substantially Equivalent on 1990-02-16. Applicant: Ivex Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Ivex Medical, 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
- Englewood, CO, US
Recent devices under product code HGX
view all- K262125 — Nenesupply Venus Handsfree Breast Pump (NBP001-HF)
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- 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 Ivex Medical, 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.