FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GE DATEX-OHMEDA AVANCE CS2
K Number: K123125
·
Decision Feb 6, 2013
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
187
Applicant Total
58
Review Days
125
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Basic Information
- Device Name
- GE DATEX-OHMEDA AVANCE CS2
- K Number
- K123125
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5160
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Datex-Ohmeda, Inc.
- Date Received
- October 4, 2012
- Decision Date
- February 6, 2013
- Product Code
- BSZ
- 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 |
|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | FDA class 2 | Anesthesiology |
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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 |
| K140575 | ENGSTROM CARESTATION, ENGSTROM PRO | Feb 3, 2015 | Substantially Equivalent |