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)

CARBONAID C02 DIFFUSER

K-Number: K112975 · 2012-06-22

ApplicantCardia Innovation AB
Decision Date2012-06-22
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CARBONAID C02 DIFFUSER is the device name listed in this FDA 510(k) record. The listed applicant is Cardia Innovation AB. It received FDA 510(k) clearance on 2012-06-22 under 510(k) number K112975. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARBONAID C02 DIFFUSER?

CARBONAID C02 DIFFUSER is a medical device that received FDA 510(k) clearance on 2012-06-22. The listed applicant is Cardia Innovation AB. The 510(k) number is K112975.

When did CARBONAID C02 DIFFUSER receive FDA 510(k) clearance?

CARBONAID C02 DIFFUSER received FDA 510(k) clearance on 2012-06-22, under 510(k) number K112975.

Who is the listed applicant for CARBONAID C02 DIFFUSER?

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

What is the FDA product code for CARBONAID C02 DIFFUSER?

The FDA product code for CARBONAID C02 DIFFUSER is HIF.

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 Cardia Innovation AB 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.

K052125CARBONAID GAS DIFFUSER

Related Devices (Code: HIF)

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.

K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KGK252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation

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.

↑