FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104
K Number: K024309
·
Decision Feb 21, 2003
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
57
Applicant Total
2
Review Days
59
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Basic Information
- Device Name
- THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104
- K Number
- K024309
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5665
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Respiratory
- Date Received
- December 24, 2002
- Decision Date
- February 21, 2003
- Product Code
- BYI
- 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 |
|---|---|---|---|
| BYI | Percussor, Powered-Electric | FDA class 2 | Anesthesiology |
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Other Clearances by Advanced Respiratory
| K Number | Device Name | ||
|---|---|---|---|
| K012928 | ABI VEST AIRWAY CLEARANCE SYSTEM | Oct 9, 2001 | Substantially Equivalent |