CipherOx CRI Tablet
FDA 510(k) clearance DEN160020 · decided 2016-12-21
Clearance details
- K-number
- DEN160020
- Device name
- CipherOx CRI Tablet
- Applicant
- Flashback Technologies, Inc.
- Decision
- Unknown
- Date received
- 2016-05-24
- Decision date
- 2016-12-21
- Days to decision
- 211 days
- Clearance type
- Direct
- Product code
- PPW
- Device class
- 2
- Regulation number
- 870.2200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Boulder, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.