TrueView 100 Pro
FDA 510(k) clearance K202713 · decided 2020-11-18
Clearance details
- K-number
- K202713
- Device name
- TrueView 100 Pro
- Applicant
- Compai Healthcare (Shenzhen) Co.,Ltd
- Decision
- Substantially Equivalent
- Date received
- 2020-09-16
- Decision date
- 2020-11-18
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- MWP
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| Kubtec Mozart (Xpert42) (K183624) | Kub Technologies, Inc. | 2019-06-20 |
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Recalls involving this device
No recalls on record reference this clearance.