The following data is part of a premarket notification filed by Zephyr Sleep Technologies Inc with the FDA for Remotely Controlled Mandibular Positioner, Rcmp.
| Device ID | K103704 |
| 510k Number | K103704 |
| Device Name: | REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP |
| Classification | Device, Anti-snoring |
| Applicant | ZEPHYR SLEEP TECHNOLOGIES INC 2513 17 ST SE Calgary; Alberta, CA T2l 2k7 |
| Contact | Sabina Bruchlmann |
| Correspondent | Sabina Bruchlmann ZEPHYR SLEEP TECHNOLOGIES INC 2513 17 ST SE Calgary; Alberta, CA T2l 2k7 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-20 |
| Decision Date | 2012-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B406CKT000000300100 | K103704 | 000 |