NEOSHIELD
FDA 510(k) clearance K172499 · decided 2018-06-01
Clearance details
- K-number
- K172499
- Device name
- NEOSHIELD
- Applicant
- JMS North America Corporation
- Decision
- Substantially Equivalent
- Date received
- 2017-08-18
- Decision date
- 2018-06-01
- Days to decision
- 287 days
- Clearance type
- Traditional
- Product code
- ONB
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Hayward, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.