Checkpoint, Checkpoint Head & Neck
FDA 510(k) clearance K150005 · decided 2015-02-19
Clearance details
- K-number
- K150005
- Device name
- Checkpoint, Checkpoint Head & Neck
- Applicant
- Ndi Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-01-02
- Decision date
- 2015-02-19
- Days to decision
- 48 days
- Clearance type
- Special
- Product code
- ETN
- Device class
- 2
- Regulation number
- 874.1820
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.