Data / Medical devices / Italy / Cosmed S.R.L.

Cosmed S.R.L.: FDA-registered device maker in Albano Laziale, Roma, Italy, 10 510(k) clearances

Name: Cosmed S.R.L. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Cosmed S.R.L. is registered with the FDA (registration 8021084) in Albano Laziale, Roma, Italy. It lists 7 device types. The FDA files 10 510(k) clearances under its listings, the newest dated February 6, 2020. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Cosmed S.R.L.

FDA registration number: 8021084
FEI number: 2995
Address: Via Dei Piani Di Monte Savello 37, Albano Laziale, Roma, Italy, 00041
Owner or operator: COSMED S.R.L. (8021084)
Roles: Exporter to the US, Manufacturer, Repackager or relabeler
First device listed: May 29, 2003
Registered through: 2026
Brand names listed: COSMED MicroQuark, COSMED PONY FX, COSMED SRL COSMED FITMATE, K4 Portable Metabolic Measurement, K5, K5 - Wearable Metabolic Technology, Q-Box, Q-NRG and more

Devices it lists

Device	Product code	Class	Role	Source
Calculator, Predicted Values, Pulmonary Function	BTY	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Calculator, Pulmonary Function Data	BZC	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Computer, Oxygen-Uptake	BZL	2	Manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Repackager or relabeler	accessdata.fda.gov
Oximeter	DQA	2	Manufacturer	accessdata.fda.gov
Spirometer, Diagnostic	BZG	2	Manufacturer	accessdata.fda.gov
Ventilator, Continuous, Facility Use	CBK	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 6, 2020	K190800	Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors	BTY	Substantially Equivalent	Cosmed Srl	accessdata.fda.gov
June 20, 2017	K162515	COSMED K5 Wearable Metabolic Technology	BZC	Substantially Equivalent	Cosmed Srl	accessdata.fda.gov
December 11, 2012	K120146	QUARK SERIES	CBK	Substantially Equivalent	Cosmed Srl	accessdata.fda.gov
February 26, 2010	K093174	SPIROPALM	BZG	Substantially Equivalent	Cosmed Srl	accessdata.fda.gov
April 25, 2008	K080141	PC ECG 1200W SYSTEM	MWI	Substantially Equivalent	Norav Medical , Ltd.	accessdata.fda.gov
September 28, 2007	K071533	FITMATE SERIES	BZL	Substantially Equivalent	Cosmed Srl	accessdata.fda.gov
September 28, 2004	K040549	COSMED PONY FX	BTY	Substantially Equivalent	Cosmed Srl	accessdata.fda.gov
January 2, 2003	K020745	COSMED MICROQUARK	BTY	Substantially Equivalent	Cosmed Srl	accessdata.fda.gov
November 22, 2000	K000404	PC ECG 1200	MWI	Substantially Equivalent	Norav Medical , Ltd.	accessdata.fda.gov
September 10, 1997	K963373	COSMED K4	BZC	Substantially Equivalent	Cosmed Srl	accessdata.fda.gov

Compare with other makers

Updated February 6, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.