FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Getinge Assured MI Steam Migrating Integrator
K Number: K242795
·
Decision Oct 15, 2024
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
264
Applicant Total
1
Review Days
29
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Basic Information
- Device Name
- Getinge Assured MI Steam Migrating Integrator
- K Number
- K242795
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Steritec Products Mfg. (A Getinge Group Company)
- Date Received
- September 16, 2024
- Decision Date
- October 15, 2024
- Product Code
- JOJ
- 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 |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | FDA class 2 | General Hospital |
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