NERVE LOCATOR/MONITOR SYSTEM MODIFICATION
FDA 510(k) clearance K954601 · decided 1995-12-22
Clearance details
- K-number
- K954601
- Device name
- NERVE LOCATOR/MONITOR SYSTEM MODIFICATION
- Applicant
- Rln Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-09-12
- Decision date
- 1995-12-22
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- ETN
- Device class
- 2
- Regulation number
- 874.1820
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Jefferson City, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.