FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
SPIRO-BALL
K Number: K053149
·
Decision Dec 13, 2005
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
107
Applicant Total
5
Review Days
33
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
- SPIRO-BALL
- K Number
- K053149
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5690
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Leventon, S.A.
- Date Received
- November 10, 2005
- Decision Date
- December 13, 2005
- Product Code
- BWF
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BWF | Spirometer, Therapeutic (Incentive) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BWF), ordered by most recent decision date.
InSee
FDA 510(k)
FDA Class 2
·Anesthesiology
AllPEP
FDA 510(k)
FDA Class 2
·Anesthesiology
LungTrainer (MD2 & MD3)
FDA 510(k)
FDA Class 2
·Anesthesiology
Breathe+
FDA 510(k)
FDA Class 2
·Anesthesiology
Hudson RCI Triflo II Incentive Deep Breathing Exerciser
FDA 510(k)
FDA Class 2
·Anesthesiology
Pulsehaler
FDA 510(k)
FDA Class 2
·Anesthesiology