FDA 510(k), K153239, LSFG-NAVI
FDA 510(k), K153239, LSFG-NAVI
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510(K) Number: K153239
Device Name: LSFG-NAVI
Manufacturer: Softcare Co., Ltd
Device Classification Name: Camera, Ophthalmic, Ac-Powered
Regulation Number: 886.1120
Classification Product Code: HKI
Date Received: 11/09/2015
Decision Date: 05/12/2016
Regulation Medical Specialty: Ophthalmic
Device Name: LSFG-NAVI
Manufacturer: Softcare Co., Ltd
Device Classification Name: Camera, Ophthalmic, Ac-Powered
Regulation Number: 886.1120
Classification Product Code: HKI
Date Received: 11/09/2015
Decision Date: 05/12/2016
Regulation Medical Specialty: Ophthalmic
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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