NEUROSCREEN SOFTWARE FOR USE WITH THE NEUROSIGN 100 NERVE MONITOR
FDA 510(k) clearance K951641 · decided 1995-05-09
Clearance details
- K-number
- K951641
- Device name
- NEUROSCREEN SOFTWARE FOR USE WITH THE NEUROSIGN 100 NERVE MONITOR
- Applicant
- The Magstim Company , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1995-03-21
- Decision date
- 1995-05-09
- Days to decision
- 49 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
- Carmarthenshire, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch The Magstim Company
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.