5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+
FDA 510(k) clearance K200864 · decided 2020-05-19
Clearance details
- K-number
- K200864
- Device name
- 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+
- Applicant
- Shenzhen Beacon Display Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-04-01
- Decision date
- 2020-05-19
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- PGY
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.