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FDA 510(k)

MULTIX Impact, MULTIX Impact C

K-Number: K213700 · 2021-12-13

Decision Date2021-12-13
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MULTIX Impact, MULTIX Impact C is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2021-12-13 under 510(k) number K213700. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTIX Impact, MULTIX Impact C?

MULTIX Impact, MULTIX Impact C is a medical device that received FDA 510(k) clearance on 2021-12-13. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K213700.

When did MULTIX Impact, MULTIX Impact C receive FDA 510(k) clearance?

MULTIX Impact, MULTIX Impact C received FDA 510(k) clearance on 2021-12-13, under 510(k) number K213700.

Who is the listed applicant for MULTIX Impact, MULTIX Impact C?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTIX Impact, MULTIX Impact C?

The FDA product code for MULTIX Impact, MULTIX Impact C is KPR.

Other records listing Siemens Medical Solutions USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 252 devices →

Related Devices (Code: KPR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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