Philips BlueControl
FDA 510(k) clearance K171055 · decided 2017-07-06
Clearance details
- K-number
- K171055
- Device name
- Philips BlueControl
- Applicant
- Philips Electronics Nederland B.V.
- Decision
- Substantially Equivalent
- Date received
- 2017-04-10
- Decision date
- 2017-07-06
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- ONE
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Eindhoven, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.