FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLUTTER(R)
K Number: K946083
·
Decision Mar 13, 1995
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
57
Applicant Total
4
Review Days
90
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
- FLUTTER(R)
- K Number
- K946083
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5665
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bradstreet Clinical Research Assoc., Inc.
- Date Received
- December 13, 1994
- Decision Date
- March 13, 1995
- 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.
AffloVest® Mobile Airway Clearance Therapy
FDA 510(k)
FDA Class 2
·Anesthesiology
BreatheBand® (Model 1000)
FDA 510(k)
FDA Class 2
·Anesthesiology
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