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

FDA 510(k)

Diagnostic Station DS20

K-Number: K152043 · 2016-05-06

ApplicantSchiller AG
Decision Date2016-05-06
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Diagnostic Station DS20 is a medical device manufactured by Schiller AG. It received FDA 510(k) clearance on 2016-05-06 under approval number K152043. 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 Diagnostic Station DS20?

Diagnostic Station DS20 is a medical device that received FDA 510(k) clearance on 2016-05-06. It is manufactured by Schiller AG. The 510(k) number is K152043.

When was Diagnostic Station DS20 approved by the FDA?

Diagnostic Station DS20 received FDA 510(k) clearance on 2016-05-06, under approval number K152043.

What company makes Diagnostic Station DS20?

Diagnostic Station DS20 is manufactured by Schiller AG.

What is the FDA product code for Diagnostic Station DS20?

The FDA product code for Diagnostic Station DS20 is DPS.

Other Devices by Schiller AG

K170182CARDIOVIT FT-1 K183425CARDIOVIT AT-102 G2 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 K151135MODEL 621/624 BIOMAGNETOMETERTristan Technologies, 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.

↑