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FDA 510(k), K181016, Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
FDA 510(k), K181016, Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
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510(K) Number: K181016
Device Name: Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
Manufacturer: Megan Pellenz
Device Classification Name: System, Image Management, Ophthalmic
Regulation Number: NFJ
Classification Product Code: KXA
Date Received: 04/17/2018
Decision Date: 07/16/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
Device Name: Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
Manufacturer: Megan Pellenz
Device Classification Name: System, Image Management, Ophthalmic
Regulation Number: NFJ
Classification Product Code: KXA
Date Received: 04/17/2018
Decision Date: 07/16/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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