5000Z FIREFLY SYSTEM— 510(k) K133502
Substantially EquivalentPrizm Medical, Inc.
FDA 510(k) clearance K133502 for 5000Z FIREFLY SYSTEM, Substantially Equivalent on 2014-12-03. Applicant: Prizm Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Prizm Medical, Inc.
- Product code
- Code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Chaska, MN, US
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