I-PAD
FDA 510(k) clearance K062970 · decided 2008-01-22
Clearance details
- K-number
- K062970
- Device name
- I-PAD
- Applicant
- Cu Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-09-29
- Decision date
- 2008-01-22
- Days to decision
- 480 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Stillwater, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.