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)

CARDITTE MICROTEL

K-Number: K082124 · 2009-02-19

ApplicantEt Medical Devices Spa
Decision Date2009-02-19
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDITTE MICROTEL is the device name listed in this FDA 510(k) record. The listed applicant is Et Medical Devices Spa. It received FDA 510(k) clearance on 2009-02-19 under 510(k) number K082124. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDITTE MICROTEL?

CARDITTE MICROTEL is a medical device that received FDA 510(k) clearance on 2009-02-19. The listed applicant is Et Medical Devices Spa. The 510(k) number is K082124.

When did CARDITTE MICROTEL receive FDA 510(k) clearance?

CARDITTE MICROTEL received FDA 510(k) clearance on 2009-02-19, under 510(k) number K082124.

Who is the listed applicant for CARDITTE MICROTEL?

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

What is the FDA product code for CARDITTE MICROTEL?

The FDA product code for CARDITTE MICROTEL is DPS.

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 Et Medical Devices Spa 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.

K091054WALK400HK051534CARDIOLINE AR 600, AR 1200, AR 2100

Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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.

↑