GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784)
FDA 510(k) clearance K062580 · decided 2007-12-21
Clearance details
- K-number
- K062580
- Device name
- GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784)
- Applicant
- GE Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2006-08-31
- Decision date
- 2007-12-21
- Days to decision
- 477 days
- Clearance type
- Traditional
- Product code
- GXY
- Device class
- 2
- Regulation number
- 882.1320
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Needham, MA, 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.
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|---|---|---|
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| Invenia ABUS 2.0 Automated Breast Ultrasound System (P110006/S009) | GE Healthcare | 2018-05-11 |
| Senographe Pristina 3D (P130020/S003) | GE Healthcare | 2017-12-28 |
| Invenia ABUS Autoated Breast Ultrasound System (P110006/S008) | GE Healthcare | 2017-09-07 |
| Invenia ABUS - Automated Breast Ultrasound System (P110006/S007) | GE Healthcare | 2017-05-01 |