DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431
FDA 510(k) clearance K002992 · decided 2001-08-15
Clearance details
- K-number
- K002992
- Device name
- DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431
- Applicant
- Medtronic Functional Diagnostics A/S
- Decision
- Substantially Equivalent
- Date received
- 2000-09-25
- Decision date
- 2001-08-15
- Days to decision
- 324 days
- Clearance type
- Traditional
- Product code
- IKT
- Device class
- 2
- Regulation number
- 890.1385
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Skovlunde, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.