Cer-S

Q: When was Cer-S cleared by the FDA?

Cer-S (K193177) received a 510(k) decision of Substantially Equivalent on August 26, 2020, 282 days after the submission was received.

Q: What is the product code of K193177?

The FDA product code is MLO – Electrocardiograph, Ambulatory, With Analysis Algorithm, a Class II (moderate risk) device regulated under 21 CFR 870.2800.

FDA 510(k) K193177 · Cardiocalm

Substantially Equivalent

510(k) numberK193177

Submission

Device name: Cer-S
Applicant: Cardiocalm
Montichiari, IT
Received: November 18, 2019
Decision date: August 26, 2020
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MLO – Electrocardiograph, Ambulatory, With Analysis Algorithm
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.2800
Specialty: Cardiovascular

Other 510(k)s with product code MLO

510(k)	Device	Applicant	Decision
K261580	ZBPro Diagnostic (Version 2.0)MLO · Traditional	Zbeats, Inc.	09/11/2026SE
K241890	Philips Holter Analysis SystemMLO · Traditional	Philips Medizin Systeme Böblingen GmbH	03/21/2025SE
K240794	Frontier X PlusMLO · Traditional	Fourth Frontier Technologies Pvt, Ltd.	11/08/2024SE
K200833	RX-1 Rhythm Express Remote Cardiac Monitoring SystemMLO · Traditional	VivaQuant, Inc.	09/02/2020SE
K182030	Faros MobileMLO · Abbreviated	Bittium Biosignals , Ltd.	11/08/2018SE
K140847	Cardiospy ECG Holter SystemsMLO · Traditional	Labtech Kft.	12/05/2014SE
K131897	CV3000 Holter Analysis SystemMLO · Traditional	Vales & Hills Biomedical Tech. , Ltd.	11/26/2013SE
K130660	Audicor Cpam with SDB (Single Sensor)MLO · Traditional	Inovise Medical, Inc.	10/11/2013SE
K120462	Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…MLO · Traditional	Inovise Medical, Inc.	09/20/2012SE
K111487	NH-301 Ambulatory ECG Analysis SoftwareMLO · Special	Norav Medical Corp.	11/10/2011SE

More from Norav Medical Corp.

510(k)	Device	Decision
K243312	Cer-SDQK · Traditional	02/20/2025SE
K213861	Cer-SDQK · Traditional	04/25/2022SE

Questions and answers

When was Cer-S cleared by the FDA?

Cer-S (K193177) received a 510(k) decision of Substantially Equivalent on August 26, 2020, 282 days after the submission was received.

What is the product code of K193177?

The FDA product code is MLO – Electrocardiograph, Ambulatory, With Analysis Algorithm, a Class II (moderate risk) device regulated under 21 CFR 870.2800.