FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER
K Number: K031259
·
Decision May 12, 2003
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
4
Review Days
21
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Basic Information
- Device Name
- MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER
- K Number
- K031259
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Getinge USA, Inc.
- Date Received
- April 21, 2003
- Decision Date
- May 12, 2003
- Product Code
- FLE
- 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 |
|---|---|---|---|
| FLE | Sterilizer, Steam | FDA class 2 | General Hospital |
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