IN-VISION IMAGING SYSTEM
FDA 510(k) clearance K031148 · decided 2003-05-28
Clearance details
- K-number
- K031148
- Device name
- IN-VISION IMAGING SYSTEM
- Applicant
- Jomed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-10
- Decision date
- 2003-05-28
- Days to decision
- 48 days
- Clearance type
- Special
- Product code
- DXK
- Device class
- 2
- Regulation number
- 870.2330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Rancho Cordova,, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.