Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8021084

FEI Number

2995

Entity Name

COSMED S.R.L.

City/State/Country

ALBANO LAZIALE, ROMA, IT

Establishment Address

VIA DEI PIANI DI MONTE, SAVELLO 37, ALBANO LAZIALE, ROMA 00041, IT

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

COSMED S.R.L. (Owner Number: 8021084)

Owner / Operator Contact Address

VIA DEI PIANI DI MONTE SAVELLO 37, ALBANO LAZIALE, IT-RM 00041, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K080141

PMA Number

N/A

All Registered Proprietary Names

Q-NRG Q-NRG+ Quark PFT Quark Series Quark CPET Quark RMR Quark PFT Body Q-Box Quark SPIRO Spiropalm Series COSMED PONY FX Quark T12x

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2020-02-12
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2013-04-19
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2013-04-19
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2010-03-24
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2003-05-29
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2003-05-29
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2016-09-19

Official Correspondent

Andrea Duca

US Agent Details

Sheemah Kazi Business: COSMED USA Inc Email: SKazi@cosmed.com Phone: (925) 6763724

Related Public Records

Same Entity

COSMED S.R.L.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27
K082966	Covidien, Formerly Nellcor Puritan Bennett, Inc.	PB 540 VENTILATOR	2008-10-31
K923989	Sensor Medics Corp.	SENSORMEDICS MODEL 6200 AUTOBOX DL	1993-08-09
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2015	Respironics California Inc	2	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Z-0018-2011	Draeger Medical Systems, Inc.	2	Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Z-0112-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Z-0180-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Z-0338-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980A1ENNISB

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3008072932	SHAPE MEDICAL SYSTEMS, INC	Saint Paul, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8021084. Last updated year: 2026. Please use registration number 8021084 when referencing this establishment in official correspondence.