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FDA 510(k), K212412, IRIS-XP
FDA 510(k), K212412, IRIS-XP
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510(K) Number: K212412
Device Name: IRIS-XP
Manufacturer: Medicore Co., Ltd.
Device Classification Name: System, Telethermographic (Adjunctive Use)
Regulation Number: 884.2980
Classification Product Code: LHQ
Date Received: 08/03/2021
Decision Date: 09/13/2021
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: IRIS-XP
Manufacturer: Medicore Co., Ltd.
Device Classification Name: System, Telethermographic (Adjunctive Use)
Regulation Number: 884.2980
Classification Product Code: LHQ
Date Received: 08/03/2021
Decision Date: 09/13/2021
Regulation Medical Specialty: Obstetrics/Gynecology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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