FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COSMED PONY FX
K Number: K040549
·
Decision Sep 28, 2004
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
62
Applicant Total
10
Review Days
210
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- COSMED PONY FX
- K Number
- K040549
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1890
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cosmed Srl
- Date Received
- March 2, 2004
- Decision Date
- September 28, 2004
- Product Code
- BTY
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTY | Calculator, Predicted Values, Pulmonary Function | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTY), ordered by most recent decision date.
Ascent Cardiorespiratory Diagnostic Software
FDA 510(k)
FDA Class 2
·Anesthesiology
SpiroSphere, SpiroSphereECG, CardioSphere
FDA 510(k)
FDA Class 2
·Anesthesiology
Pulmonary Function Tester, Model: A9
FDA 510(k)
FDA Class 2
·Anesthesiology
Virtus Metabolic Monitor
FDA 510(k)
FDA Class 2
·Anesthesiology
Model 9100 PFT/DICO
FDA 510(k)
FDA Class 2
·Anesthesiology
MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Cosmed Srl
| K Number | Device Name | ||
|---|---|---|---|
| K190800 | Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors | Feb 6, 2020 | Substantially Equivalent |
| K162515 | COSMED K5 Wearable Metabolic Technology | Jun 20, 2017 | Substantially Equivalent |
| K120146 | QUARK SERIES | Dec 11, 2012 | Substantially Equivalent |
| K093174 | SPIROPALM | Feb 26, 2010 | Substantially Equivalent |
| K071533 | FITMATE SERIES | Sep 28, 2007 | Substantially Equivalent |
| K020745 | COSMED MICROQUARK | Jan 2, 2003 | Substantially Equivalent |
| K014262 | COSMED QUARK C12/QUARK T12 | Mar 26, 2002 | Substantially Equivalent |
| K001174 | COSMED QUARK | Jan 11, 2001 | Substantially Equivalent |
| K963373 | COSMED K4 | Sep 10, 1997 | Substantially Equivalent |