Personal 120/210 Basic Electrocardiograph

FDA 510(k) K902368 · Esaote Biomedica Spa

Substantially Equivalent

510(k) numberK902368

Submission

Device name
Personal 120/210 Basic Electrocardiograph
Applicant
Esaote Biomedica Spa
Cambridge, MA, US
Received
May 29, 1990
Decision date
September 11, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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
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K240229Masimo W1DPS · Traditional Masimo Corporation08/08/2024SE

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Questions and answers

When was Personal 120/210 Basic Electrocardiograph cleared by the FDA?

Personal 120/210 Basic Electrocardiograph (K902368) received a 510(k) decision of Substantially Equivalent on September 11, 1990, 105 days after the submission was received.

What is the product code of K902368?

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