FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE
K Number: K021376
·
Decision Jul 24, 2002
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
40
Review Days
84
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE
- K Number
- K021376
- 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
- May 1, 2002
- Decision Date
- July 24, 2002
- Product Code
- DSI
- 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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DSI), ordered by most recent decision date.
BodyGuardian Remote Monitoring System (BGRMS v3.0)
FDA 510(k)
FDA Class 2
·Cardiovascular
MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
FDA 510(k)
FDA Class 2
·Cardiovascular
Zio AT® device (A100A1001)
FDA 510(k)
FDA Class 2
·Cardiovascular
MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
FDA 510(k)
FDA Class 2
·Cardiovascular
SmartCardia 7L Platform
FDA 510(k)
FDA Class 2
·Cardiovascular
Unified Arrhythmia Diagnostic System PocketECG IV
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |