PS-41 6M Patient Simulator

FDA 510(k) K963198 · Metron U.S., Inc.

Substantially Equivalent

510(k) numberK963198

Submission

Device name
PS-41 6M Patient Simulator
Applicant
Metron U.S., Inc.
Grand Rapids, MI, US
Received
August 15, 1996
Decision date
March 5, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DPS – Electrocardiograph
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2340
Specialty
Cardiovascular

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K252361AccurECG Analysis System (v2.0)DPS · Traditional Accurkardia, Inc.12/22/2025SE
K252474Withings BeamO (SCT02)DPS · Traditional Withings11/10/2025SE
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K243252ZBPro DiagnosticDPS · Traditional Zbeats, Inc.07/10/2025SE
K243305Masimo W1DPS · Traditional Masimo Corporation04/03/2025SE
K241217CloudHRV™ System (100-01-001)DPS · Traditional Inmedix, Inc.01/16/2025SE
K241556Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional Philips Medizin Systeme Böblingen GmbH12/17/2024SE
K240229Masimo W1DPS · Traditional Masimo Corporation08/08/2024SE

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K973991Metron QA-510 SPO2 AnalyzerDQA · Traditional 01/16/1998SE
K963190QA-40M Defibrillator TesterDRL · Traditional 07/01/1997SE

Questions and answers

When was PS-41 6M Patient Simulator cleared by the FDA?

PS-41 6M Patient Simulator (K963198) received a 510(k) decision of Substantially Equivalent on March 5, 1997, 202 days after the submission was received.

What is the product code of K963198?

The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.