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FDA 510(k)

MOBILETT Impact

K-Number: K231577 · 2023-07-25

Decision Date2023-07-25
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOBILETT Impact is a medical device manufactured by Siemens Medical Solutions. It received FDA 510(k) clearance on 2023-07-25 under approval number K231577. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOBILETT Impact?

MOBILETT Impact is a medical device that received FDA 510(k) clearance on 2023-07-25. It is manufactured by Siemens Medical Solutions. The 510(k) number is K231577.

When was MOBILETT Impact approved by the FDA?

MOBILETT Impact received FDA 510(k) clearance on 2023-07-25, under approval number K231577.

What company makes MOBILETT Impact?

MOBILETT Impact is manufactured by Siemens Medical Solutions.

What is the FDA product code for MOBILETT Impact?

The FDA product code for MOBILETT Impact is IZL.

Other Devices by Siemens Medical Solutions

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Related Devices (Code: IZL)

Official Source

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