FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE
K Number: K022740
·
Decision Nov 14, 2002
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
13
Applicant Total
40
Review Days
87
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Basic Information
- Device Name
- DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE
- K Number
- K022740
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Datex-Ohmeda
- Date Received
- August 19, 2002
- Decision Date
- November 14, 2002
- Product Code
- MLD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| MLD | Monitor, St Segment With Alarm | FDA class 2 | Cardiovascular |
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| K071142 | GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM | Jun 6, 2007 | Substantially Equivalent |
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| 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 |