Product code HCS
- Device name
- Device, Temperature Measurement, Direct Contact, Powered
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.1570
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K981805 | POS T-7000 | Pos Technologies, Inc. | 1998-08-07 |
| K974208 | TYTRON C-3000 | Titronics Research & Development Co. | 1998-02-03 |
| K950986 | NEUROREADER | Artronics | 1995-11-09 |
| K894772 | THERMALGRAPHIC ANALYSER | Medtech Instruments | 1989-10-03 |
| K840487 | T-METER | K.J. Electronics | 1984-03-12 |
| K831995 | TRENDO-SCOPE | Gabriel Ent. | 1983-08-08 |
| K822795 | GABRIEL DIGITREND | Gabriel Ent. | 1982-10-08 |
| K821107 | EXOPHTHALMOMETER | Medical Equipment Designs, Inc. | 1982-06-14 |
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|---|---|---|---|
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| 00853818007378 | USB Charging Cable | PRECISION BIOMETRICS INC | 2017-12-13 |
| 00853818007347 | MyoVision Wirefree System | PRECISION BIOMETRICS INC | 2017-11-03 |
| 00853818007330 | USB Charger | PRECISION BIOMETRICS INC | 2017-02-20 |
| 00853818007323 | USB 2.0 Cable (WireFree) | PRECISION BIOMETRICS INC | 2016-12-31 |
| 00853818007316 | Flexlite Charging Cable | PRECISION BIOMETRICS INC | 2016-12-31 |
| 00853818007309 | Myovision Charging Cable | PRECISION BIOMETRICS INC | 2016-12-31 |
| 00853818007262 | DynaVision Belts | PRECISION BIOMETRICS INC | 2016-12-19 |
| 00853818007200 | Power Cable for PB-204 (North American - Type B) (WireFree) | PRECISION BIOMETRICS INC | 2016-12-13 |
| 00853818007293 | Power Supply for WireFree | PRECISION BIOMETRICS INC | 2016-12-13 |
| 00853818007286 | Dynamic Lead Wire Set | PRECISION BIOMETRICS INC | 2016-12-13 |
| 00853818007279 | MyoPad Vault | PRECISION BIOMETRICS INC | 2016-12-13 |
| 00853818007255 | QuickScan Pads & Electrodes Pack | PRECISION BIOMETRICS INC | 2016-12-13 |
| 00853818007224 | ScanVision electrodes | PRECISION BIOMETRICS INC | 2016-12-13 |
| 00853818007217 | Power Cable for PB-204 (UK/Ireland - Type G) (WireFree) | PRECISION BIOMETRICS INC | 2016-12-13 |
| 00853818007194 | Power Cable for PB-204 (EU - Type E/F) (WireFree) | PRECISION BIOMETRICS INC | 2016-12-13 |
| 00853818007187 | USB 2.0 Cable (WireFree) | PRECISION BIOMETRICS INC | 2016-12-13 |
| 00853818007156 | QuickScan Pads | PRECISION BIOMETRICS INC | 2016-12-07 |
| 00853818007125 | DynaVision Dynamic sEMG Electrodes | PRECISION BIOMETRICS INC | 2016-12-07 |
| 00853818007101 | MyoVision Software | PRECISION BIOMETRICS INC | 2016-11-27 |
| 00853818007095 | MyoVision Software | PRECISION BIOMETRICS INC | 2016-11-27 |
| 00853818007088 | MyoVision Software | PRECISION BIOMETRICS INC | 2016-11-27 |
| 00853818007071 | MyoVision Software | PRECISION BIOMETRICS INC | 2016-11-27 |
| 00853818007064 | MyoVision Software | PRECISION BIOMETRICS INC | 2016-11-27 |
| 00853818007057 | MyoVision Software | PRECISION BIOMETRICS INC | 2016-11-27 |
| 00853818007002 | MyoVision Wirefree System | PRECISION BIOMETRICS INC | 2016-11-15 |
| 00853818007040 | MyoVision Wirefree System | PRECISION BIOMETRICS INC | 2016-11-15 |
| 00853818007033 | MyoVision Wirefree System | PRECISION BIOMETRICS INC | 2016-11-15 |
| 00853818007026 | MyoVision Wirefree System | PRECISION BIOMETRICS INC | 2016-11-15 |
| 00853818007019 | MyoVision Wirefree System | PRECISION BIOMETRICS INC | 2016-11-15 |