PureLift— 510(k) K190269
Substantially EquivalentXtreem Pulse, LLC
FDA 510(k) clearance K190269 for PureLift, Substantially Equivalent on 2019-08-28. Applicant: Xtreem Pulse, LLC. Device class: 2.
Clearance details
- Applicant
- Xtreem Pulse, LLC
- Product code
- Code NFO
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
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