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)

MONICA AN24

K-Number: K112390 · 2012-07-13

ApplicantMonica Healthcare, Ltd.
Decision Date2012-07-13
Product CodeOSP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MONICA AN24 is the device name listed in this FDA 510(k) record. The listed applicant is Monica Healthcare, Ltd.. It received FDA 510(k) clearance on 2012-07-13 under 510(k) number K112390. The device is classified under product code OSP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONICA AN24?

MONICA AN24 is a medical device that received FDA 510(k) clearance on 2012-07-13. The listed applicant is Monica Healthcare, Ltd.. The 510(k) number is K112390.

When did MONICA AN24 receive FDA 510(k) clearance?

MONICA AN24 received FDA 510(k) clearance on 2012-07-13, under 510(k) number K112390.

Who is the listed applicant for MONICA AN24?

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

What is the FDA product code for MONICA AN24?

The FDA product code for MONICA AN24 is OSP.

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

Related Devices (Code: OSP)

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.

K190798LaborView™ LV1000 Wireless Electrode SystemObmedical CompanyK153262PUREtrace™Nemo Healthcare BVK130002SURECALL LABOR MONITORReproductive Research Technologies, LPK112163MONICA IF24Monica HealthcareK101801MONICA AN24Monica HealthcareK090145SURECALL EMG LABOR MONITORReproductive Research Technologies, LP

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.

↑