MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED
FDA 510(k) clearance K092391 · decided 2010-04-01
Clearance details
- K-number
- K092391
- Device name
- MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED
- Applicant
- Concord Medical Products
- Decision
- Substantially Equivalent
- Date received
- 2009-08-05
- Decision date
- 2010-04-01
- Days to decision
- 239 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Burlington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.