FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
SpiroSphere, SpiroSphereECG, CardioSphere
K Number: K223629
·
Decision May 28, 2024
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
62
Applicant Total
3
Review Days
540
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
- SpiroSphere, SpiroSphereECG, CardioSphere
- K Number
- K223629
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1890
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eresearchtechnology GmbH
- Date Received
- December 5, 2022
- Decision Date
- May 28, 2024
- Product Code
- BTY
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- CV
- Third Party
- Y
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
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
Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors
FDA 510(k)
FDA Class 2
·Anesthesiology