SMARTWAVE MS 2000— 510(k) K041063
Substantially EquivalentNewwave Medical, LLC
FDA 510(k) clearance K041063 for SMARTWAVE MS 2000, Substantially Equivalent on 2004-12-01. Applicant: Newwave Medical, LLC. Device class: 2.
Clearance details
- Applicant
- Newwave Medical, LLC
- Product code
- Code IPF
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plano, TX, US
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