FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AMERSE 2
K Number: K983947
·
Decision Dec 4, 1998
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
72
Applicant Total
169
Review Days
29
Basic Information
- Device Name
- AMERSE 2
- K Number
- K983947
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6890
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- STERIS Corporation
- Date Received
- November 5, 1998
- Decision Date
- December 4, 1998
- Product Code
- LRJ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LRJ | Disinfectant, Medical Devices | FDA class 1 | General Hospital |
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