The following data is part of a premarket notification filed by Sophono Inc. with the FDA for Sophono Bone Conduction Systems (s) Configuration And (m) Configuration.
| Device ID | K153391 |
| 510k Number | K153391 |
| Device Name: | Sophono Bone Conduction Systems (S) Configuration And (M) Configuration |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | SOPHONO INC. 5744 CENTRAL AVE #100 Boulder, CO 80301 |
| Contact | Rozanne Paciej |
| Correspondent | Rozanne Paciej SOPHONO INC. 5744 CENTRAL AVE #100 Boulder, CO 80301 |
| Product Code | LXB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-24 |
| Decision Date | 2016-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169719545 | K153391 | 000 |
| 00643169719668 | K153391 | 000 |
| 00643169719675 | K153391 | 000 |
| 00643169719682 | K153391 | 000 |
| 00643169719699 | K153391 | 000 |
| 00643169719705 | K153391 | 000 |
| 00643169719712 | K153391 | 000 |
| 00643169719729 | K153391 | 000 |
| 00643169719736 | K153391 | 000 |
| 00643169719651 | K153391 | 000 |
| 00643169719644 | K153391 | 000 |
| 00643169719637 | K153391 | 000 |
| 00643169719552 | K153391 | 000 |
| 00643169719569 | K153391 | 000 |
| 00643169719576 | K153391 | 000 |
| 00643169719583 | K153391 | 000 |
| 00643169719590 | K153391 | 000 |
| 00643169719606 | K153391 | 000 |
| 00643169719613 | K153391 | 000 |
| 00643169719620 | K153391 | 000 |
| 00643169719743 | K153391 | 000 |
| 00643169719750 | K153391 | 000 |
| 00643169719958 | K153391 | 000 |
| 00643169719972 | K153391 | 000 |
| 00643169719989 | K153391 | 000 |
| 00643169862210 | K153391 | 000 |
| 00643169862227 | K153391 | 000 |
| 00643169862234 | K153391 | 000 |
| 00643169862241 | K153391 | 000 |
| 00643169868854 | K153391 | 000 |
| 00643169719941 | K153391 | 000 |
| 00643169719859 | K153391 | 000 |
| 00643169719842 | K153391 | 000 |
| 00643169719767 | K153391 | 000 |
| 00643169719774 | K153391 | 000 |
| 00643169719781 | K153391 | 000 |
| 00643169719798 | K153391 | 000 |
| 00643169719804 | K153391 | 000 |
| 00643169719811 | K153391 | 000 |
| 00643169719828 | K153391 | 000 |
| 00643169719835 | K153391 | 000 |
| 00643169930780 | K153391 | 000 |