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FDA 510(k)

CARDIOVIT AT-102 G2

K-Number: K183425 · 2020-03-02

ApplicantSchiller AG
Decision Date2020-03-02
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOVIT AT-102 G2 is a medical device manufactured by Schiller AG. It received FDA 510(k) clearance on 2020-03-02 under approval number K183425. 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-102 G2?

CARDIOVIT AT-102 G2 is a medical device that received FDA 510(k) clearance on 2020-03-02. It is manufactured by Schiller AG. The 510(k) number is K183425.

When was CARDIOVIT AT-102 G2 approved by the FDA?

CARDIOVIT AT-102 G2 received FDA 510(k) clearance on 2020-03-02, under approval number K183425.

What company makes CARDIOVIT AT-102 G2?

CARDIOVIT AT-102 G2 is manufactured by Schiller AG.

What is the FDA product code for CARDIOVIT AT-102 G2?

The FDA product code for CARDIOVIT AT-102 G2 is DPS.

Other Devices by Schiller AG

K152043Diagnostic Station DS20 K170182CARDIOVIT FT-1 K221056ARGUS PB-3000

Related Devices (Code: DPS)

K160746CARDIOLINE touchECGCardioline S.P.A K160840ECG100+, ECG200+Cardioline S.P.A K152135Quantitative Electrocardiographic Detector (QED 2000)Acme Portable Machines, Inc. K161302PC ECGEdan Instruments, Inc. K152863Portable ECG MonitorContec Medical Systems Co.,Ltd K152043Diagnostic Station DS20Schiller AG

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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