Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ORICARE L2700

K-Number: K122875 · 2012-12-18

ApplicantOricare, Inc.
Decision Date2012-12-18
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ORICARE L2700 is the device name listed in this FDA 510(k) record. The listed applicant is Oricare, Inc.. It received FDA 510(k) clearance on 2012-12-18 under 510(k) number K122875. The device is classified under product code FSY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORICARE L2700?

ORICARE L2700 is a medical device that received FDA 510(k) clearance on 2012-12-18. The listed applicant is Oricare, Inc.. The 510(k) number is K122875.

When did ORICARE L2700 receive FDA 510(k) clearance?

ORICARE L2700 received FDA 510(k) clearance on 2012-12-18, under 510(k) number K122875.

Who is the listed applicant for ORICARE L2700?

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

What is the FDA product code for ORICARE L2700?

The FDA product code for ORICARE L2700 is FSY.

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 Oricare, 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.

K120931CRITICAL CARE VENTILATORK113338MEDICAL AIR COMPRESSOR

Related Devices (Code: FSY)

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.

K132747VISUM BLADE LED SURGICAL LIGHTING SYSTEMStryker CommunicationsK132307VIDA LED SURGICAL LIGHTING SYSTEMConvida Healthcare & Systems CorporationK131893AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTSAjw Technology Consultants, Inc.K120392CHROMOPHARE F 628 AND F 528Berchtold GmbH & Co. KGK102758TRULIGHT 5520 AND TRULIGHT 5320Trumpf Kreuzer Medizin Systeme GmbH + Co.KgK101537AIM 200, MAJOR SURGICAL LIGHTBurton Medical Products Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑