FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENGSTROM CARESTATION, ENGSTROM PRO
K Number: K140575
·
Decision Feb 3, 2015
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
504
Applicant Total
58
Review Days
334
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Basic Information
- Device Name
- ENGSTROM CARESTATION, ENGSTROM PRO
- K Number
- K140575
- 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, Inc.
- Date Received
- March 6, 2014
- Decision Date
- February 3, 2015
- 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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Other Clearances by Datex-Ohmeda, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K210384 | CARESCAPE R860 | Nov 4, 2021 | Substantially Equivalent |
| K172702 | Tec 820, Tec 850 | Jan 4, 2018 | Substantially Equivalent |
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| K170872 | Aisys CS2 | Aug 15, 2017 | Substantially Equivalent |
| K151570 | Carestation 620/650/650C | Jan 21, 2016 | Substantially Equivalent |
| K142679 | CARESCAPE R860 | Jun 12, 2015 | Substantially Equivalent |
| K143530 | Aespire View | Apr 24, 2015 | Substantially Equivalent |
| K132530 | GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) | Dec 20, 2013 | Substantially Equivalent |