510(k) K964622
- Device
- MEDI-DX 7000
- Applicant
- NEURO-DIAGNOSTIC ASSOC.
- 510(k) number
- K964622
- Product code
- LLN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-12-01
- Date received
- 1996-11-18
- Regulation
- 882.1200
- Classification name
- Device, Vibration Threshold Measurement
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES HEDGECOCK
- Address
- 445 Dartmoor St. Laguna Beach CA US 92651 92651
FDA Registration Numbers#
- 3027307766
- 1121806
- 2118418
- 3027555919
- 3011504786
- 8044062
- 3011276311
Source Documents#
Other 510(k) Records For Product Code LLN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K072882 | PAIN VISION, MODEL PS-2100 | Osachi Co., Ltd. | 2009-01-08 |
| K030829 | VPT METER | Xilas Medical, Inc. | 2003-12-05 |
| K010981 | GSA GENITO SENSORY ANALYZER | Medoc Ltd. Advanced Medical Systems | 2001-09-20 |
| K964815 | AP-4000, AIR PULSE SENSORY STIMULATOR | Pentax Precision Instrument Corp. | 1997-09-04 |
| 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 |
| K843486 | VIBRAMETER | Somedic AB | 1984-12-24 |
Legacy Summary#
summary
FDA Review#
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