FDA Product Code
FDA Product Code GXB — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1500
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K143068 | Medical Monofilament Sensory Screening Toool | Medical Monofilament Manufacturing | 2015-01-14 | Traditional | PDF ↗ |
| K933798 | NU-PREP GEL | Cadwell Laboratories, Inc. | 1994-04-22 | Traditional | PDF ↗ |
| K871571 | NEUROTIPS(TM) | Ulster Scientific, Inc. | 1987-06-18 | Traditional | PDF ↗ |
| K801907 | ALGESIOMETER | Rowan Products, Inc. | 1980-09-16 | Traditional | PDF ↗ |
| K772406 | AESTHESIOMETER | Fred Sammons, Inc. | 1978-01-06 | Traditional | PDF ↗ |
| K771847 | TEMP-TESTER | Jablecki, Charles, Dr. | 1977-11-02 | Traditional | PDF ↗ |
| K761133 | AESTHESIOMETER | Fred Sammons, Inc. | 1976-12-02 | Traditional | PDF ↗ |
Product code GXB · Class I · Neurology. Data: openFDA.