FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES
K Number: K020479
·
Decision Mar 26, 2002
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
40
Review Days
41
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Basic Information
- Device Name
- DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES
- K Number
- K020479
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Datex-Ohmeda
- Date Received
- February 13, 2002
- Decision Date
- March 26, 2002
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
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Other Clearances by Datex-Ohmeda
| K Number | Device Name | ||
|---|---|---|---|
| K131945 | GE DATEX-OHMEDA AVANCE CS2 | Aug 8, 2013 | Substantially Equivalent |
| K122445 | AESPIRE 7900, AESPIRE VIEW | Oct 12, 2012 | Substantially Equivalent |
| K111116 | ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000 | Sep 9, 2011 | Substantially Equivalent |
| K071142 | GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM | Jun 6, 2007 | Substantially Equivalent |
| K042891 | DATEX-OHMEDA OXY-AFR SENSOR | Jun 29, 2005 | Substantially Equivalent |
| K043572 | COMPATIBILITY ECG TRUNK CABLES | Feb 22, 2005 | Substantially Equivalent |
| K043551 | DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES | Feb 18, 2005 | Substantially Equivalent |
| K043276 | DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE | Dec 23, 2004 | Substantially Equivalent |
| K042771 | GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3 | Oct 15, 2004 | Substantially Equivalent |
| K041772 | DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACCESSORIES | Jul 28, 2004 | Substantially Equivalent |