FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTRO FLO PERCUSSOR, MODEL 5000
K Number: K031876
·
Decision Nov 21, 2003
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
55
Applicant Total
3
Review Days
157
Basic Information
- Device Name
- ELECTRO FLO PERCUSSOR, MODEL 5000
- K Number
- K031876
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5665
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MED SYSTEMS
- Date Received
- June 17, 2003
- Decision Date
- November 21, 2003
- 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 |
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