The Luco Hybrid OSA Appliance
FDA 510(k) clearance K160477 · decided 2016-07-29
Clearance details
- K-number
- K160477
- Device name
- The Luco Hybrid OSA Appliance
- Applicant
- Luco Hybrid Osa Appliance, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-02-19
- Decision date
- 2016-07-29
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- OCO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Kingston, CA
- 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.
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|---|---|---|
| TMJ Relax (K202523) | Moonwalker Innovations, Inc. | 2021-06-24 |
| NTI TENSION SUPPRESSION SYSTEM (K010876) | Nti-Tss, Inc. | 2001-06-20 |
Recalls involving this device
No recalls on record reference this clearance.