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FDA 510(k), K220090, Visibly Digital Acuity Product
FDA 510(k), K220090, Visibly Digital Acuity Product
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510(K) Number: K220090
Device Name: Visibly Digital Acuity Product
Manufacturer: Visibly, Inc.
Device Classification Name: Digital Visual Acuity Test
Regulation Number: 886.1150
Classification Product Code: QTO
Date Received: 01/11/2022
Decision Date: 08/12/2022
Regulation Medical Specialty: Ophthalmic
Device Name: Visibly Digital Acuity Product
Manufacturer: Visibly, Inc.
Device Classification Name: Digital Visual Acuity Test
Regulation Number: 886.1150
Classification Product Code: QTO
Date Received: 01/11/2022
Decision Date: 08/12/2022
Regulation Medical Specialty: Ophthalmic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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