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)

CARIEL F12

K-Number: K823934 · 1983-12-16

ApplicantOdam
Decision Date1983-12-16
Product CodeDYC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARIEL F12 is the device name listed in this FDA 510(k) record. The listed applicant is Odam. It received FDA 510(k) clearance on 1983-12-16 under 510(k) number K823934. The device is classified under product code DYC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARIEL F12?

CARIEL F12 is a medical device that received FDA 510(k) clearance on 1983-12-16. The listed applicant is Odam. The 510(k) number is K823934.

When did CARIEL F12 receive FDA 510(k) clearance?

CARIEL F12 received FDA 510(k) clearance on 1983-12-16, under 510(k) number K823934.

Who is the listed applicant for CARIEL F12?

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

What is the FDA product code for CARIEL F12?

The FDA product code for CARIEL F12 is DYC.

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 Odam 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.

K972535MAGLIFE CK950264MAGLIFEK854175DEFIGARD 2000K823931DEFIGARD M(OR DEFISCOPE MK823933MINIDEF (OR DEFIPORT

Related Devices (Code: DYC)

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.

K023414MIDA ALGORITHM REV. BOrtivus ABK896396MIDA SYSTEM, MODELS 1000/1100Medical Graphics Corp.K810529DIRECT WRITING VECTORCARDIOGRAPHElmed, Inc.

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.

↑