Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)
FDA 510(k) clearance K240289 · decided 2024-10-23
Clearance details
- K-number
- K240289
- Device name
- Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)
- Applicant
- Scivita Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-02-01
- Decision date
- 2024-10-23
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Suzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.