UniPulse— 510(k) K182905
Substantially EquivalentSeaward Group
FDA 510(k) clearance K182905 for UniPulse, Substantially Equivalent on 2018-12-14. Applicant: Seaward Group. Device class: 2.
Clearance details
- Applicant
- Seaward Group
- Product code
- Code DRL
- Device class
- Class 2
- Regulation
- 21 CFR 870.5325
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Peterlee, GB
Recent devices under product code DRL
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