Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder
FDA 510(k) clearance K172859 · decided 2017-11-22
Clearance details
- K-number
- K172859
- Device name
- Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder
- Applicant
- Prosomnous Sleep Technologies
- Decision
- Substantially Equivalent
- Date received
- 2017-09-20
- Decision date
- 2017-11-22
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- PLC
- Device class
- 2
- Regulation number
- 872.5570
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ProSomnus RPMO2 OSA Device (RPMO2 OSA) (K252765) | Prosomnus Sleep Technologies | 2026-04-06 |
| Rest Assure System (K233497) | Somnomed, Inc. | 2024-10-03 |
| Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac (K190353) | Residential Home Sleep Services | 2020-04-10 |
| OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor (K181571) | Mark Abramson, D.D.S., Inc. | 2019-04-19 |
| Acrylic Herbst Appliance with Micro-Recorder (K170606) | Gergen'S Orthodontic Lab | 2017-11-16 |
| MicrO2 OSA Device with Micro-Recorder (K161624) | Microdental, Inc. | 2016-11-07 |
| TAP 3, TAP 1 (K160239) | Airway Management, Inc. | 2016-08-10 |
| SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder (K150369) | Somnomed, Inc. | 2015-06-18 |
Recalls involving this device
No recalls on record reference this clearance.