Electromyograph, Diagnostic
Capital 9450058 NIM Cntrl Patient INT BX
2manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Shaanxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | IKN |
| Device type | Electromyograph, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1375 |
| 510(k) | K061113 |
| Record published | 2016-07-01 |
| Record revised | 2019-02-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2018-10-08 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 945PSP1001 | 10 | In distribution | |
| 9450036 | In distribution | ||
| 9450058 | In distribution | ||
| 945VG202 | In distribution | ||
| 9450017 | In distribution | ||
| 945DSE0003 | 10 | Withdrawn | |
| 9450044 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Electromyograph, Diagnostic | Medtronic Xomed, Inc. | 36 |
| Natus | Natus Neurology Incorporated | 21 |
| Natus Neurology | Natus Neurology Incorporated | 21 |
| NVM5 | Nuvasive, Inc. | 19 |
| Epad | Safeop Surgical, Inc. | 18 |
| Pulse | Nuvasive, Inc. | 16 |
| Electromyograph, Diagnostic | Nihon Kohden Corp. | 16 |
| Electromyograph, Diagnostic | Nihon Kohden America, Inc. | 15 |
| Natus | Xltek | 14 |
| Neuropack S3 | Nihon Kohden Corp. | 8 |
| MyoVision Software | Precision Biometrics, Inc. | 5 |
| SafeOp | Alphatec Spine, Inc. | 4 |
Showing 12 of 49. All products under Electromyograph, Diagnostic
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.