CEROX MODEL 3210
FDA 510(k) clearance K093923 · decided 2010-01-19
Clearance details
- K-number
- K093923
- Device name
- CEROX MODEL 3210
- Applicant
- Or-Nim Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-12-22
- Decision date
- 2010-01-19
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- MUD
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Lod, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.