945PSP1000
by Medtronic Sofamor Danek, Inc.
945PSP1000 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K061113 on 23 May 2006 and listed in FDA GUDID since 2 Oct 2016 (UDI-DI 00613994480125), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00613994480125 | Date2 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK061113 | Date23 May 2006 | StatusActive |
Official records
- AccessGUDID record 00613994480125
- FDA 510(k) database K061113
Across registries
- FDA 510(k) K061113 decided 23 May 2006 Active
- FDA GUDID UDI-DI 00613994480125 listed 2 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K061113
- Listed FDA GUDID 00613994480125
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Nerve-locating system
- Model / reference
- 945PSP1000
- Primary DI / UDI-DI
- 00613994480125
- 510(k) Number
- FDA product code
- GWF
- GMDN term
- Nerve-locating system
- Device class
- Class II
- Regulation number
- 882.1870
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 100.0 Millimeter
Similar devices
Other devices filed under FDA product code GWF (STIMULATOR, ELECTRICAL, EVOKED RESPONSE).
- Digitimer DS7A by Digitimer, Ltd.
- 533624 by inomed Medizintechnik GmbH
- MEP Monitor by Tonica Elektronik A/S
- CANTATA EMG/EVOKED RESPONSE SYSTEM by Dantec Medical, Inc.
- EPOCHXP NEUROLOGICAL WORKSTATION, EPOCHXP LITE NEUROLOGICAL WORKSTATION by Axon Systems, Inc.
- CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER by Cadwell Laboratories, Inc.
- TECA. MILLENNIUM by Medelec, Ltd.
- MagPro X100 9016E0711 by Tonica Elektronik A/S
- Cadwell Guardian 199332-000 by Cadwell Industries, Inc.
- NIM Vital Nerve Integrity Monitor by Medtronic Xomed Inc