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FDA 510(k)

EM-07 Cordless Endo Motor

K-Number: K232551 · 2024-07-09

Decision Date2024-07-09
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EM-07 Cordless Endo Motor is the device name listed in this FDA 510(k) record. The listed applicant is Forum Engineering Technologies (96) , Ltd.. It received FDA 510(k) clearance on 2024-07-09 under 510(k) number K232551. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EM-07 Cordless Endo Motor?

EM-07 Cordless Endo Motor is a medical device that received FDA 510(k) clearance on 2024-07-09. The listed applicant is Forum Engineering Technologies (96) , Ltd.. The 510(k) number is K232551.

When did EM-07 Cordless Endo Motor receive FDA 510(k) clearance?

EM-07 Cordless Endo Motor received FDA 510(k) clearance on 2024-07-09, under 510(k) number K232551.

Who is the listed applicant for EM-07 Cordless Endo Motor?

The FDA 510(k) record lists Forum Engineering Technologies (96) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EM-07 Cordless Endo Motor?

The FDA product code for EM-07 Cordless Endo Motor is EKX.

Related Devices (Code: EKX)

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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