SUDOSCAN— 510(k) K100233
Substantially EquivalentImpeto Medical
FDA 510(k) clearance K100233 for SUDOSCAN, Substantially Equivalent on 2010-06-14. Applicant: Impeto Medical. Device class: 2.
Clearance details
- Applicant
- Impeto Medical
- Product code
- Code GZO
- Device class
- Class 2
- Regulation
- 21 CFR 882.1540
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code GZO
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