Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump
FDA 510(k) clearance K182749 · decided 2019-06-12
Clearance details
- K-number
- K182749
- Device name
- Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump
- Applicant
- Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-09-28
- Decision date
- 2019-06-12
- Days to decision
- 257 days
- Clearance type
- Traditional
- Product code
- HGX
- Device class
- 2
- Regulation number
- 884.5160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Cigli, TR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.