FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMS PERCUSSOR
K Number: K913014
·
Decision Oct 23, 1991
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
57
Applicant Total
22
Review Days
107
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Basic Information
- Device Name
- EMS PERCUSSOR
- K Number
- K913014
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5665
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Engineered Medical Systems
- Date Received
- July 8, 1991
- Decision Date
- October 23, 1991
- 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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