NT MEDITENS PLUS, TYPE 290
FDA 510(k) clearance K014020 · decided 2002-07-11
Clearance details
- K-number
- K014020
- Device name
- NT MEDITENS PLUS, TYPE 290
- Applicant
- Bio-Medical Research, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-12-06
- Decision date
- 2002-07-11
- Days to decision
- 217 days
- Clearance type
- Traditional
- Product code
- GZJ
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Galway, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.