Spiropalm
by COSMED Srl
510(k) K093174
Spiropalm is a Class II device made by COSMED Srl, cleared under FDA 510(k) K093174 on 26 Feb 2010, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK093174 | Date26 Feb 2010 | StatusActive |
Official records
- FDA 510(k) database K093174
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BZG
- Device class
- Class II
- Regulation
- 21 CFR Part 868.1840
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K093174
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| COSMED Spiropalm | Spiropalm | 18052400180072 | — | On the market |
| COSMED Spiropalm 6MWT | Spiropalm 6MWT | 18052400180096 | — | On the market |
Similar devices
Other devices filed under FDA product code BZG (Spirometer, Diagnostic).
- EZ-1 System Respiratory Effort Sensors by Pro-Tech, Inc.
- Airway Thermistor by Synectics-Dantec
- Spiromate AS-600 by Riko Medical & Scientific Instrument Corp.
- Spiromate AS-500 by Riko Medical & Scientific Instrument Corp.
- SPIRO ANALYZER ST-300 by Futuremed Div. of Future Impex Corp.
- Alveoair Digital Spirometer by Roundworks Technologies Private Limited
- SALTER VOLUCHEK 6600 by SALTER LABS
- VIT-O-METER by Health Scan, Inc.
- VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6) by Vitalograph Ireland, Ltd.
- HMS-5000 by Vitalog Monitoring, Inc.