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FDA 510(k)

AB CARDIETTE START 200 HV

K-Number: K010822 · 2001-04-18

ApplicantH&C Medical Devices Spa
Decision Date2001-04-18
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AB CARDIETTE START 200 HV 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 2001-04-18 under 510(k) number K010822. 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 START 200 HV?

AB CARDIETTE START 200 HV is a medical device that received FDA 510(k) clearance on 2001-04-18. The listed applicant is H&C Medical Devices Spa. The 510(k) number is K010822.

When did AB CARDIETTE START 200 HV receive FDA 510(k) clearance?

AB CARDIETTE START 200 HV received FDA 510(k) clearance on 2001-04-18, under 510(k) number K010822.

Who is the listed applicant for AB CARDIETTE START 200 HV?

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 START 200 HV?

The FDA product code for AB CARDIETTE START 200 HV 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 HOMEK002074AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES

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.

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