Esthesiometer
FDA product code GXB · Class I (low risk) · 21 CFR 882.1500 · Neurology
7510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143068 | Medical Monofilament Sensory Screening TooolGXB · Traditional | Medical Monofilament Manufacturing | 01/14/2015SE |
| K933798 | Nu-Prep GelGXB · Traditional | Cadwell Laboratories, Inc. | 04/22/1994SE |
| K871571 | Neurotips(Tm)GXB · Traditional | Ulster Scientific, Inc. | 06/18/1987SE |
| K801907 | AlgesiometerGXB · Traditional | Rowan Products, Inc. | 09/16/1980SE |
| K772406 | AesthesiometerGXB · Traditional | Fred Sammons, Inc. | 01/06/1978SE |
| K771847 | Temp-TesterGXB · Traditional | Jablecki, Charles, Dr. | 11/02/1977SE |
| K761133 | AesthesiometerGXB · Traditional | Fred Sammons, Inc. | 12/02/1976SE |