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)

ICRCO 3600M

K-Number: K122510 · 2013-04-26

ApplicantIcrco, Inc.
Decision Date2013-04-26
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ICRCO 3600M is the device name listed in this FDA 510(k) record. The listed applicant is Icrco, Inc.. It received FDA 510(k) clearance on 2013-04-26 under 510(k) number K122510. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICRCO 3600M?

ICRCO 3600M is a medical device that received FDA 510(k) clearance on 2013-04-26. The listed applicant is Icrco, Inc.. The 510(k) number is K122510.

When did ICRCO 3600M receive FDA 510(k) clearance?

ICRCO 3600M received FDA 510(k) clearance on 2013-04-26, under 510(k) number K122510.

Who is the listed applicant for ICRCO 3600M?

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

What is the FDA product code for ICRCO 3600M?

The FDA product code for ICRCO 3600M is MUE.

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 Icrco, 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.

K120753CLARISCTK113449FUSION FLAT PANELK082450IDR

Related Devices (Code: MUE)

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.

K254090I-View®Hologic, Inc.K253678MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc.K254092Bellalun 2D (VDMS-1000S)Vieworks Co., Ltd.K260087Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightGE Medical Systems SCSK243420HESTIAGenoray Co., Ltd.K2438492430TCA with Xmaru WRayence Co., Ltd.

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.

↑