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: 07/23/2021
Date Received: 09/21/2021
Decision Date: 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: 07/23/2021
Date Received: 09/21/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
- 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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