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FDA 510(k)

AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES

K-Number: K002074 · 2000-10-04

ApplicantH&C Medical Devices Spa
Decision Date2000-10-04
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES is the device name listed in this FDA 510(k) record. The listed applicant is H&C Medical Devices Spa. It received FDA 510(k) clearance on 2000-10-04 under 510(k) number K002074. 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 AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES?

AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES is a medical device that received FDA 510(k) clearance on 2000-10-04. The listed applicant is H&C Medical Devices Spa. The 510(k) number is K002074.

When did AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES receive FDA 510(k) clearance?

AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES received FDA 510(k) clearance on 2000-10-04, under 510(k) number K002074.

Who is the listed applicant for AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES?

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

What is the FDA product code for AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES?

The FDA product code for AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES is DPS.

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Other records listing H&C 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.

K012012ECG HOMEK010822AB CARDIETTE START 200 HV

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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