ICON, MODEL C3— 510(k) K082242
Substantially EquivalentOsypka Medical, Inc.
FDA 510(k) clearance K082242 for ICON, MODEL C3, Substantially Equivalent on 2008-10-08. Applicant: Osypka Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Osypka Medical, Inc.
- Product code
- Code DSB
- Device class
- Class 2
- Regulation
- 21 CFR 870.2770
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- La Jolla, CA, US
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