Cosmed S.r.l.
ALBANO LAZIALE, ROMA Roma, IT
COSMED S.R.L. appears in FDA device records in ALBANO LAZIALE, ROMA Roma, IT. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Cosmed S.r.l. between 1997 and 2020. The busiest year on record is 1997, with 1. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2007 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2017 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K190800 | Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors | BTY | Substantially Equivalent | |
| K162515 | COSMED K5 Wearable Metabolic Technology | BZC | Substantially Equivalent | |
| K120146 | QUARK SERIES | CBK | Substantially Equivalent | |
| K093174 | SPIROPALM | BZG | Substantially Equivalent | |
| K071533 | FITMATE SERIES | BZL | Substantially Equivalent | |
| K040549 | COSMED PONY FX | BTY | Substantially Equivalent | |
| K020745 | COSMED MICROQUARK | BTY | Substantially Equivalent | |
| K014262 | COSMED QUARK C12/QUARK T12 | DPS | Substantially Equivalent | |
| K001174 | COSMED QUARK | BZC | Substantially Equivalent | |
| K963373 | COSMED K4 | BZC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8021084 | 2995 | COSMED S.R.L. | VIA DEI PIANI DI MONTE, ALBANO LAZIALE, ROMA 00041 IT | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain