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FDA 510(k)

deepLive (OSP12 + DMS)

K-Number: K252851 · 2025-10-07

ApplicantDamae Medical
Decision Date2025-10-07
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

deepLive (OSP12 + DMS) is the device name listed in this FDA 510(k) record. The listed applicant is Damae Medical. It received FDA 510(k) clearance on 2025-10-07 under 510(k) number K252851. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the deepLive (OSP12 + DMS)?

deepLive (OSP12 + DMS) is a medical device that received FDA 510(k) clearance on 2025-10-07. The listed applicant is Damae Medical. The 510(k) number is K252851.

When did deepLive (OSP12 + DMS) receive FDA 510(k) clearance?

deepLive (OSP12 + DMS) received FDA 510(k) clearance on 2025-10-07, under 510(k) number K252851.

Who is the listed applicant for deepLive (OSP12 + DMS)?

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

What is the FDA product code for deepLive (OSP12 + DMS)?

The FDA product code for deepLive (OSP12 + DMS) is NQQ.

Other records listing Damae Medical 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.

K240610deepLive

Related Devices (Code: NQQ)

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.

K253459OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)ABBOTT MEDICALK251730LIA Console (542-7)Leadoptik, Inc.K253101HyperVue™ Imaging System - IntegratedSpectrawave, Inc.K251198HyperVue™ SoftwareSpectrawave, Inc.K250684OPUSWAVE Dual Sensor Imaging SystemTerumo Cardiovascular Systems Thi PlantK242924OPXION Optical Skin Viewer (OPXSV1-01F)Opxion Technology, Inc.

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.

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