FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES
K Number: K021955
·
Decision Oct 8, 2002
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
58
Review Days
116
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Basic Information
- Device Name
- TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES
- K Number
- K021955
- 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, Inc.
- Date Received
- June 14, 2002
- Decision Date
- October 8, 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, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K172702 | Tec 820, Tec 850 | Jan 4, 2018 | Substantially Equivalent |
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| K170872 | Aisys CS2 | Aug 15, 2017 | Substantially Equivalent |
| K151570 | Carestation 620/650/650C | Jan 21, 2016 | Substantially Equivalent |
| K142679 | CARESCAPE R860 | Jun 12, 2015 | Substantially Equivalent |
| K143530 | Aespire View | Apr 24, 2015 | Substantially Equivalent |
| K140575 | ENGSTROM CARESTATION, ENGSTROM PRO | Feb 3, 2015 | Substantially Equivalent |