GSA GENITO SENSORY ANALYZER
FDA 510(k) clearance K010981 · decided 2001-09-20
Clearance details
- K-number
- K010981
- Device name
- GSA GENITO SENSORY ANALYZER
- Applicant
- Medoc Ltd. Advanced Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2001-04-02
- Decision date
- 2001-09-20
- Days to decision
- 171 days
- Clearance type
- Traditional
- Product code
- LLN
- Device class
- 1
- Regulation number
- 882.1200
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PAIN VISION, MODEL PS-2100 (K072882) | Osachi Co., Ltd. | 2009-01-08 |
| VPT METER (K030829) | Xilas Medical, Inc. | 2003-12-05 |
| MEDI-DX 7000 (K964622) | Neuro-Diagnostic Assoc. | 1997-12-01 |
| AP-4000, AIR PULSE SENSORY STIMULATOR (K964815) | Pentax Precision Instrument Corp. | 1997-09-04 |
| VSA 3000 VIBRATORYN SENSORY ANALYZER (K970180) | Eare Consulting Service | 1997-04-25 |
| NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001 (K934368) | Nk Biotechnical Engineering Co. | 1994-08-11 |
| VIBROTACTILE TESTER, MODEL NO. VTT-100 (K921560) | Topical Testing, Inc. | 1992-10-30 |
| CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4 (K910624) | Wr Medical Electronics Co. | 1992-01-17 |
| TECA/MEDELEC TTT THERMAL THRESHOLD TESTER (K872931) | Teca, Inc. | 1987-11-16 |
| VIBRATRON II, VIBRATION SENSITIVITY TESTER (K863607) | Sensortek, Inc. | 1986-12-03 |
| NEUROMETER (K853608) | Neurotron, Inc. | 1986-06-12 |
| VIBRAMETER (K843486) | Somedic AB | 1984-12-24 |
Recalls involving this device
No recalls on record reference this clearance.