Perifit Pump
FDA 510(k) clearance K231785 · decided 2024-01-26
Clearance details
- K-number
- K231785
- Device name
- Perifit Pump
- Applicant
- X6 Innovations
- Decision
- Substantially Equivalent
- Date received
- 2023-06-20
- Decision date
- 2024-01-26
- Days to decision
- 220 days
- Clearance type
- Traditional
- Product code
- HGX
- Device class
- 2
- Regulation number
- 884.5160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Paris, FR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.