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FDA 510(k), K212303, T2
FDA 510(k), K212303, T2
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510(K) Number: K212303
Device Name: T2
Manufacturer: Jinwoo Bae
Device Classification Name: X-Ray, Tomography, Computed, Dental
Regulation Number: OAS
Classification Product Code: KXA
Date Received: 07/23/2021
Decision Date: 09/21/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: T2
Manufacturer: Jinwoo Bae
Device Classification Name: X-Ray, Tomography, Computed, Dental
Regulation Number: OAS
Classification Product Code: KXA
Date Received: 07/23/2021
Decision Date: 09/21/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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