Diagnostic Station DS20

FDA UDI

Class I (US FDA UDI)

by Schiller Corp.

Identity

Trade Name: Diagnostic Station DS20 FDA UDI
Generic Name: Electrocardiograph, professional, multichannel FDA UDI
Device Name: The Diagnostic Station DS20 is a 12-lead ECG device that is intended for use in the recording, analysis and evaluation of ECG waveforms. The DS20 is also intended for the collection and recording of basic vital signs on adult and pediatric patients, excluding neonates. FDA UDI
Model / Reference: 3.930535 FDA UDI
Description: The Diagnostic Station DS20 is a 12-lead ECG device that is intended for use in the recording, analysis and evaluation of ECG waveforms. The DS20 is also intended for the collection and recording of basic vital signs on adult and pediatric patients, excluding neonates. FDA UDI

Identifiers

Catalog Number: 3.930535 FDA UDI
Primary DI / UDI-DI: 07613365000498 FDA UDI
510(k) Number: K152043 FDA UDI
FDA Product Code: JKS FDA UDI
FLL FDA UDI
BZQ FDA UDI
MWI FDA UDI
DQA FDA UDI
BZG FDA UDI
DXN FDA UDI
DPS FDA UDI
GMDN Term: Electrocardiograph, professional, multichannel FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.3220 FDA UDI
880.2910 FDA UDI
868.2375 FDA UDI
870.2300 FDA UDI
870.2700 FDA UDI
868.1840 FDA UDI
870.1130 FDA UDI
870.2340 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Electrocardiograph, professional, multichannel

Diagnostic Station DS20 by Schiller Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K152043 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Schiller Corp.

Sources (1)

FDA UDI 01adb9cf-8542-47f7-841a-e89e20fde379 37 fields · synced May 30, 2026