Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Schiller AG. It received FDA 510(k) clearance on 2020-03-02 under 510(k) 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. The listed applicant is Schiller AG. The 510(k) number is K183425.

When did CARDIOVIT AT-102 G2 receive FDA 510(k) clearance?

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

Who is the listed applicant for CARDIOVIT AT-102 G2?

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-102 G2?

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

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-3000K170182CARDIOVIT FT-1K152043Diagnostic Station DS20

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.

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 CommercialK243252ZBPro DiagnosticZbeats, Inc.

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.

↑