DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75
FDA 510(k) clearance K990375 · decided 1999-03-09
Clearance details
- K-number
- K990375
- Device name
- DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75
- Applicant
- Medtronic Functional Diagnostics A/S
- Decision
- Substantially Equivalent
- Date received
- 1999-02-08
- Decision date
- 1999-03-09
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- IKT
- Device class
- 2
- Regulation number
- 890.1385
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Copenhagen, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.