Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| PMAM 1122 125mm | 1600337 | Bien-Air Surgery SA | ERL | 07630055505149 |
| PMRM 1122 70mm | 1600206 | Bien-Air Surgery SA | ERL | 07630055505040 |
| PMAM 1221 125mm | 1600339 | Bien-Air Surgery SA | ERL | J00716003390011 |
| PMAM 10121 70mm | 1600202 | Bien-Air Surgery SA | ERL | J00716002020011 |
| Fisch PM Micro | 1600470 | Bien-Air Surgery SA | ERL | J00716004700011 |
| Set OSSEODOC + BASCH-1 + Pump | 1700525 | Bien-Air Surgery SA | ERL | J00717005250011 |
| Set OSSEODOC + BASCH + Pump | 1700168 | Bien-Air Surgery SA | ERL | J00717001680011 |
| Set OSSEODOC + BASCH-1 | 1700541 | Bien-Air Surgery SA | ERL | 17630055506228 |
| OSSEODOC Control Unit + Pump | 1600331 | Bien-Air Surgery SA | ERL | J00716003310011 |
| PMAM 1221 70 mm | 1600295 | Bien-Air Surgery SA | ERL | 07630055505095 |
| PMAM 1221 70 mm | 1600295 | Bien-Air Surgery SA | ERL | J00716002950011 |
| PM 1124 46mm | 1600612 | Bien-Air Surgery SA | ERL | 07630055505538 |
| BASCH-1 Micromotor | 1600884 | Bien-Air Surgery SA | ERL | J00716008840011 |
| Set OSSEODOC + BASCH | 1700169 | Bien-Air Surgery SA | ERL | 17630055506013 |
| BASCH Micromotor + Cable | 1700074 | Bien-Air Surgery SA | ERL | J00717000740011 |
| Set OSSEODOC | 1700348 | Bien-Air Surgery SA | ERL | 17630055508147 |
| PMRM 1122 95mm | 1600340 | Bien-Air Surgery SA | ERL | J00716003400011 |
| BASCH-1 Micromotor + Cable | 1700502 | Bien-Air Surgery SA | ERL | 17630055506150 |
| OSSEODOC Control Unit | 1600332 | Bien-Air Surgery SA | ERL | J00716003320011 |
| PMAM 1122 70mm | 1600207 | Bien-Air Surgery SA | ERL | J00716002070011 |
| PMRM 1122 70mm | 1600206 | Bien-Air Surgery SA | ERL | J00716002060011 |
| Set OSSEODOC + BASCH | 1700169 | Bien-Air Surgery SA | ERL | J00717001690011 |
| PMAM 1122 125mm | 1600337 | Bien-Air Surgery SA | ERL | J00716003370011 |
| Set OSSEODOC + BASCH-1 | 1700541 | Bien-Air Surgery SA | ERL | J00717005410011 |
| PM 1124 46mm | 1600612 | Bien-Air Surgery SA | ERL | J00716006120011 |