Physioglove Es with ECG Analysis

FDA 510(k) K103791 · Commwell , Ltd.

Substantially Equivalent

510(k) numberK103791

Submission

Device name
Physioglove Es with ECG Analysis
Applicant
Commwell , Ltd.
Kfar Saba, IL
Received
December 27, 2010
Decision date
October 21, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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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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

More from Masimo Corporation

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K083677Physioglove for Use with Physioglove ES1DRX · Traditional 03/10/2009SE
K050674Physioglove EsDPS · Traditional 04/25/2006SE

Questions and answers

When was Physioglove Es with ECG Analysis cleared by the FDA?

Physioglove Es with ECG Analysis (K103791) received a 510(k) decision of Substantially Equivalent on October 21, 2011, 298 days after the submission was received.

What is the product code of K103791?

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