AED Sinuscope
FDA 510(k) clearance K170285 · decided 2017-08-01
Clearance details
- K-number
- K170285
- Device name
- AED Sinuscope
- Applicant
- National Advanced Endoscopy Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-01-30
- Decision date
- 2017-08-01
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- EOB
- Device class
- 2
- Regulation number
- 874.4760
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Canoga Park, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.