EMPOWERMR INJECTOR SYSTEM, MODEL 9730
FDA 510(k) clearance K062449 · decided 2007-04-13
Clearance details
- K-number
- K062449
- Device name
- EMPOWERMR INJECTOR SYSTEM, MODEL 9730
- Applicant
- E-Z-Em, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-08-22
- Decision date
- 2007-04-13
- Days to decision
- 234 days
- Clearance type
- Abbreviated
- Product code
- IZQ
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Westbury, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.