FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU)
K Number: K050676
·
Decision Apr 12, 2005
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
186
Applicant Total
50
Review Days
27
Basic Information
- Device Name
- GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU)
- K Number
- K050676
- 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
- March 16, 2005
- Decision Date
- April 12, 2005
- 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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Other Clearances by DATEX-OHMEDA, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K151570 | Carestation 620/650/650C | Jan 21, 2016 | Substantially Equivalent |
| K140575 | ENGSTROM CARESTATION, ENGSTROM PRO | Feb 3, 2015 | Substantially Equivalent |
| K132530 | GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) | Dec 20, 2013 | Substantially Equivalent |
| K123125 | GE DATEX-OHMEDA AVANCE CS2 | Feb 6, 2013 | Substantially Equivalent |
| K112722 | GE DATEX-OHMEDA AVANCE | Dec 16, 2011 | Substantially Equivalent |
| K110213 | GE DATEX-OHMEDA AISYS | Jul 20, 2011 | Substantially Equivalent |
| K090233 | GE DATEX-OHMEDA AISYS | Mar 5, 2009 | Substantially Equivalent |
| K081842 | ENGSTROM CARESTATION, ENGSTROM PRO | Oct 3, 2008 | Substantially Equivalent |
| K081844 | GE DATEX-OHMEDA AVANCE | Aug 29, 2008 | Substantially Equivalent |
| K073707 | GE DATEX-OHMEDA AISYS | Jan 30, 2008 | Substantially Equivalent |