The following data is part of a premarket notification filed by Simavita Pty Limited with the FDA for Sim.
| Device ID | K130951 |
| 510k Number | K130951 |
| Device Name: | SIM |
| Classification | Alarm, Conditioned Response Enuresis |
| Applicant | SIMAVITA PTY LIMITED 555 13TH ST. NW Washington, DC 20004 |
| Contact | John J Smith, Md,jd |
| Correspondent | John J Smith, Md,jd SIMAVITA PTY LIMITED 555 13TH ST. NW Washington, DC 20004 |
| Product Code | KPN |
| CFR Regulation Number | 876.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-05 |
| Decision Date | 2013-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09342124000667 | K130951 | 000 |
| 09342124000469 | K130951 | 000 |
| 09342124000452 | K130951 | 000 |
| 09342124000445 | K130951 | 000 |
| 09342124000391 | K130951 | 000 |
| 09342124000421 | K130951 | 000 |
| 09342124000384 | K130951 | 000 |
| 09342124000377 | K130951 | 000 |
| 09342124000360 | K130951 | 000 |
| 09342124000353 | K130951 | 000 |
| 09342124000346 | K130951 | 000 |
| 09342124000339 | K130951 | 000 |
| 09342124000322 | K130951 | 000 |
| 09342124000315 | K130951 | 000 |
| 09342124000308 | K130951 | 000 |
| 09342124000292 | K130951 | 000 |
| 09342124000285 | K130951 | 000 |
| 09342124000476 | K130951 | 000 |
| 09342124000483 | K130951 | 000 |
| 09342124000490 | K130951 | 000 |
| 09342124000650 | K130951 | 000 |
| 09342124000643 | K130951 | 000 |
| 09342124000636 | K130951 | 000 |
| 09342124000629 | K130951 | 000 |
| 09342124000612 | K130951 | 000 |
| 09342124000605 | K130951 | 000 |
| 09342124000599 | K130951 | 000 |
| 09342124000582 | K130951 | 000 |
| 09342124000575 | K130951 | 000 |
| 09342124000568 | K130951 | 000 |
| 09342124000551 | K130951 | 000 |
| 09342124000544 | K130951 | 000 |
| 09342124000537 | K130951 | 000 |
| 09342124000520 | K130951 | 000 |
| 09342124000513 | K130951 | 000 |
| 09342124000506 | K130951 | 000 |
| 09342124000162 | K130951 | 000 |