FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
Model 9100 PFT/DICO
K Number: K221030
·
Decision Jul 15, 2022
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
62
Applicant Total
5
Review Days
99
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
- Model 9100 PFT/DICO
- K Number
- K221030
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1890
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vitalograph Ireland, Ltd.
- Date Received
- April 7, 2022
- Decision Date
- July 15, 2022
- 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
MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU
FDA 510(k)
FDA Class 2
·Anesthesiology
Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Vitalograph Ireland, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K223818 | Model 9160 VitaloQUB | May 25, 2023 | Substantially Equivalent |
| K212938 | Vitalograph Model 6000 Alpha | Jan 26, 2022 | Substantially Equivalent |
| K201562 | Spirotrac | Oct 14, 2020 | Substantially Equivalent |
| K200550 | Vitalograph Model 2120 In2itive eDiary | Jul 27, 2020 | Substantially Equivalent |