ENERGEX
FDA 510(k) clearance K042686 · decided 2005-06-16
Clearance details
- K-number
- K042686
- Device name
- ENERGEX
- Applicant
- Energex Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-29
- Decision date
- 2005-06-16
- Days to decision
- 260 days
- Clearance type
- Traditional
- Product code
- NHH
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ORTHOSONIX ENERGEX (K013094) | Orthosonix, Inc. | 2001-12-14 |
Recalls involving this device
No recalls on record reference this clearance.