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FDA 510(k)

CARDIOVIT AT-10PLUS

K-Number: K050686 · 2005-05-04

ApplicantSchiller AG
Decision Date2005-05-04
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOVIT AT-10PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Schiller AG. It received FDA 510(k) clearance on 2005-05-04 under 510(k) number K050686. 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 CARDIOVIT AT-10PLUS?

CARDIOVIT AT-10PLUS is a medical device that received FDA 510(k) clearance on 2005-05-04. The listed applicant is Schiller AG. The 510(k) number is K050686.

When did CARDIOVIT AT-10PLUS receive FDA 510(k) clearance?

CARDIOVIT AT-10PLUS received FDA 510(k) clearance on 2005-05-04, under 510(k) number K050686.

Who is the listed applicant for CARDIOVIT AT-10PLUS?

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

What is the FDA product code for CARDIOVIT AT-10PLUS?

The FDA product code for CARDIOVIT AT-10PLUS is DPS.

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Other records listing Schiller AG 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.

K253562medilogFDK221056ARGUS PB-3000K183425CARDIOVIT AT-102 G2K170182CARDIOVIT FT-1K152043Diagnostic Station DS20K101619WELCH ALLYN 1500 PATIENT MONITOR

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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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