DISPOSABLE MONOPLAR MEDDLE ELECTRODES
FDA 510(k) clearance K915741 · decided 1992-12-08
Clearance details
- K-number
- K915741
- Device name
- DISPOSABLE MONOPLAR MEDDLE ELECTRODES
- Applicant
- Dantec Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-12-20
- Decision date
- 1992-12-08
- Days to decision
- 354 days
- Clearance type
- Traditional
- Product code
- GXE
- Device class
- 1
- Regulation number
- 882.4600
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.