510(k) K843486
- Device
- Vibrameter
- Applicant
- SOMEDIC AB
- 510(k) number
- K843486
- Product code
- LLN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-12-24
- Date received
- 1984-09-06
- Regulation
- 882.1200
- Classification name
- Device, Vibration Threshold Measurement
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- BO G JOHANSSON
- Address
- Box 14162 S-104 41 Stockholm Sweden US
FDA Registration Numbers#
- 8044062
- 3011276311
- 3011504786
- 2118418
- 3027307766
- 3027555919
- 1121806
Source Documents#
510(k) summary PDF not indicated by FDA
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|---|---|---|---|
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| K970180 | VSA 3000 VIBRATORYN SENSORY ANALYZER | Eare Consulting Service | 1997-04-25 |
| K934368 | NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001 | Nk Biotechnical Engineering Co. | 1994-08-11 |
| K921560 | VIBROTACTILE TESTER, MODEL NO. VTT-100 | Topical Testing, Inc. | 1992-10-30 |
| K910624 | CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4 | Wr Medical Electronics Co. | 1992-01-17 |
| K872931 | TECA/MEDELEC TTT THERMAL THRESHOLD TESTER | Teca, Inc. | 1987-11-16 |
| K863607 | VIBRATRON II, VIBRATION SENSITIVITY TESTER | Sensortek, Inc. | 1986-12-03 |
| K853608 | NEUROMETER | Neurotron, Inc. | 1986-06-12 |