Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K192545
Potenza · Jeisys Medical Incorporated · decided 2020-02-20 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| POTENZA Tip | P1-08 | Jeisys Medical Inc. | GEI | 08800020101204 |
| POTENZA Tip | S-16 | Jeisys Medical Inc. | GEI | 08800020111159 |
| (unnamed) | GEI | 08800020101525 | ||
| POTENZA | Foot Switch | Jeisys Medical Inc. | GEI | 08800020108395 |
| POTENZA Tip | S-49 | Jeisys Medical Inc. | GEI | 08800020111111 |
| POTENZA Tip | A1-15 | Jeisys Medical Inc. | GEI | 08800020101143 |
| POTENZA Tip | S-25 | Jeisys Medical Inc. | GEI | 08800020111135 |
| (unnamed) | GEI | 08800020108425 | ||
| POTENZA Tip | A1-12 | Jeisys Medical Inc. | GEI | 08800020111265 |
| POTENZA Tip | S-25 Tip | Jeisys Medical Inc. | GEI | 08800020100269 |
| POTENZA Tip | A1-15 | Jeisys Medical Inc. | GEI | 08800020111272 |
| POTENZA Tip | S-49 Tip | Jeisys Medical Inc. | GEI | 08800020100245 |
| POTENZA Tip | S-16 Tip | Jeisys Medical Inc. | GEI | 08800020101198 |
| POTENZA Tip | P1-08 | Jeisys Medical Inc. | GEI | 08800020111258 |
| POTENZA Tip | I-25 | Jeisys Medical Inc. | GEI | 08800020111128 |
| (unnamed) | GEI | 08800020108401 | ||
| POTENZA Tip | I-25 Tip | Jeisys Medical Inc. | GEI | 08800020100252 |
| POTENZA Tip | I-16 | Jeisys Medical Inc. | GEI | 08800020111142 |
| POTENZA Tip | A1-12 | Jeisys Medical Inc. | GEI | 08800020101136 |
| POTENZA Tip | I-49 Tip | Jeisys Medical Inc. | GEI | 08800020100238 |
| POTENZA Tip | I-49 | Jeisys Medical Inc. | GEI | 08800020111104 |
| POTENZA Tip | I-16 Tip | Jeisys Medical Inc. | GEI | 08800020101181 |
| POTENZA | POTENZA | Jeisys Medical Inc. | GEI | 08800020111012 |
| POTENZA Handpiece | AC Handpiece | Jeisys Medical Inc. | GEI | 08800020101754 |
| POTENZA Handpiece | Motor Handpiece | Jeisys Medical Inc. | GEI | 08800020101778 |