FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3
K Number: K042771
·
Decision Oct 15, 2004
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
116
Applicant Total
40
Review Days
10
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Basic Information
- Device Name
- GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3
- K Number
- K042771
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Datex-Ohmeda
- Date Received
- October 5, 2004
- Decision Date
- October 15, 2004
- Product Code
- MSX
- 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 |
|---|---|---|---|
| MSX | System, Network And Communication, Physiological Monitors | FDA class 2 | Cardiovascular |
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