Caption Guidance
FDA 510(k) clearance DEN190040 · decided 2020-02-07
Clearance details
- K-number
- DEN190040
- Device name
- Caption Guidance
- Applicant
- Bay Labs, Inc.
- Decision
- Unknown
- Date received
- 2019-08-27
- Decision date
- 2020-02-07
- Days to decision
- 164 days
- Clearance type
- Direct
- Product code
- QJU
- Device class
- 2
- Regulation number
- 892.2100
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.