N7-S
FDA 510(k) clearance K240168 · decided 2024-09-12
Clearance details
- K-number
- K240168
- Device name
- N7-S
- Applicant
- Nuga Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-01-22
- Decision date
- 2024-09-12
- Days to decision
- 234 days
- Clearance type
- Traditional
- Product code
- JFB
- Device class
- 2
- Regulation number
- 890.5880
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Wonju-Si, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.