FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000
K Number: K111116
·
Decision Sep 9, 2011
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
504
Applicant Total
40
Review Days
141
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Basic Information
- Device Name
- ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000
- K Number
- K111116
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Datex-Ohmeda
- Date Received
- April 21, 2011
- Decision Date
- September 9, 2011
- Product Code
- CBK
- 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | FDA class 2 | Anesthesiology |
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