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FDA 510(k)

CLUE MEDICAL AND CLUE MEDICAL BASIC

K-Number: K082013 · 2008-11-10

ApplicantTelovital GmbH Telemedizin
Decision Date2008-11-10
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CLUE MEDICAL AND CLUE MEDICAL BASIC is the device name listed in this FDA 510(k) record. The listed applicant is Telovital GmbH Telemedizin. It received FDA 510(k) clearance on 2008-11-10 under 510(k) number K082013. 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 CLUE MEDICAL AND CLUE MEDICAL BASIC?

CLUE MEDICAL AND CLUE MEDICAL BASIC is a medical device that received FDA 510(k) clearance on 2008-11-10. The listed applicant is Telovital GmbH Telemedizin. The 510(k) number is K082013.

When did CLUE MEDICAL AND CLUE MEDICAL BASIC receive FDA 510(k) clearance?

CLUE MEDICAL AND CLUE MEDICAL BASIC received FDA 510(k) clearance on 2008-11-10, under 510(k) number K082013.

Who is the listed applicant for CLUE MEDICAL AND CLUE MEDICAL BASIC?

The FDA 510(k) record lists Telovital GmbH Telemedizin as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLUE MEDICAL AND CLUE MEDICAL BASIC?

The FDA product code for CLUE MEDICAL AND CLUE MEDICAL BASIC 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 Telovital GmbH Telemedizin 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.

K083630CLUE MEDICAL AND CLUE MEDICAL BASIC

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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