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FDA 510(k)

ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+

K-Number: K151426 · 2016-01-29

ApplicantScandidos AB
Decision Date2016-01-29
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ is a medical device manufactured by Scandidos AB. It received FDA 510(k) clearance on 2016-01-29 under approval number K151426. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+?

ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ is a medical device that received FDA 510(k) clearance on 2016-01-29. It is manufactured by Scandidos AB. The 510(k) number is K151426.

When was ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ approved by the FDA?

ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ received FDA 510(k) clearance on 2016-01-29, under approval number K151426.

What company makes ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+?

ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ is manufactured by Scandidos AB.

What is the FDA product code for ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+?

The FDA product code for ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ is IYE.

Related Clinical Trials

NCT05884203 Improving Prosthetic Provision in Rural Communities: Limb Scanning With Caregiver Assistance RECRUITING

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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