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FDA 510(k)

L SOPHIA

K-Number: K901512 · 1990-07-20

ApplicantNishitomo Co., Inc.
Decision Date1990-07-20
Product CodeLHD
DecisionSubstantially Equivalent

Device Summary

L SOPHIA is the device name listed in this FDA 510(k) record. The listed applicant is Nishitomo Co., Inc.. It received FDA 510(k) clearance on 1990-07-20 under 510(k) number K901512. The device is classified under product code LHD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the L SOPHIA?

L SOPHIA is a medical device that received FDA 510(k) clearance on 1990-07-20. The listed applicant is Nishitomo Co., Inc.. The 510(k) number is K901512.

When did L SOPHIA receive FDA 510(k) clearance?

L SOPHIA received FDA 510(k) clearance on 1990-07-20, under 510(k) number K901512.

Who is the listed applicant for L SOPHIA?

The FDA 510(k) record lists Nishitomo Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for L SOPHIA?

The FDA product code for L SOPHIA is LHD.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Nishitomo Co., 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.

K021978PETIT SOPHIA

Related Devices (Code: LHD)

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.

K200163Ava Fertility TrackerAva AGK122337OVUSENSEFertility Focus, Ltd.K102499DUOFERTILITYCambridge Temperature Concepts , Ltd.K050094LADY COMP USALady Comp USAK030961MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921Microlife Corp.K021978PETIT SOPHIANishitomo Co., 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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