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FDA 510(k)

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)

K-Number: K240328 · 2024-05-16

Decision Date2024-05-16
Product CodeQNO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) is the device name listed in this FDA 510(k) record. The listed applicant is Signifier Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2024-05-16 under 510(k) number K240328. The device is classified under product code QNO. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)?

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) is a medical device that received FDA 510(k) clearance on 2024-05-16. The listed applicant is Signifier Medical Technologies, Ltd.. The 510(k) number is K240328.

When did eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) receive FDA 510(k) clearance?

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) received FDA 510(k) clearance on 2024-05-16, under 510(k) number K240328.

Who is the listed applicant for eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)?

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

What is the FDA product code for eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)?

The FDA product code for eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) is QNO.

Other records listing Signifier Medical Technologies, Ltd. 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.

Related Devices (Code: QNO)

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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