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FDA 510(k)

CARTOUCH

K-Number: K002197 · 2000-12-27

ApplicantCardionics, Inc.
Decision Date2000-12-27
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARTOUCH is the device name listed in this FDA 510(k) record. The listed applicant is Cardionics, Inc.. It received FDA 510(k) clearance on 2000-12-27 under 510(k) number K002197. 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 CARTOUCH?

CARTOUCH is a medical device that received FDA 510(k) clearance on 2000-12-27. The listed applicant is Cardionics, Inc.. The 510(k) number is K002197.

When did CARTOUCH receive FDA 510(k) clearance?

CARTOUCH received FDA 510(k) clearance on 2000-12-27, under 510(k) number K002197.

Who is the listed applicant for CARTOUCH?

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

What is the FDA product code for CARTOUCH?

The FDA product code for CARTOUCH 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.

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Other records listing Cardionics, Inc. 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.

K862776SPECTRUM POLYCORD I RECORDER SYSTEM

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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