FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE MCSHIRLEY PERCUSSOR
K Number: K801982
·
Decision Sep 16, 1980
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
55
Applicant Total
3
Review Days
28
Basic Information
- Device Name
- THE MCSHIRLEY PERCUSSOR
- K Number
- K801982
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5665
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- MCSHIRLEY PRODUCTS, INC.
- Date Received
- August 19, 1980
- Decision Date
- September 16, 1980
- Product Code
- BYI
- 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 |
|---|---|---|---|
| BYI | Percussor, Powered-Electric | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYI), ordered by most recent decision date.
LibAirty Airway Clearance System
FDA 510(k)
FDA Class 2
·Anesthesiology
Respiratory Muscle Trainer
FDA 510(k)
FDA Class 2
·Anesthesiology
The Vest APX System (PVAPX1)
FDA 510(k)
FDA Class 2
·Anesthesiology
Electromed SmartVest Airway Clearance System
FDA 510(k)
FDA Class 2
·Anesthesiology
Electro Flo 6 Airway Clearance System
FDA 510(k)
FDA Class 2
·Anesthesiology
AirPhysio Positive Expiratory Pressure (PEP) Device
FDA 510(k)
FDA Class 2
·Anesthesiology