FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
K Number: K040831
·
Decision Sep 2, 2004
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
10
Applicant Total
58
Review Days
155
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Basic Information
- Device Name
- DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
- K Number
- K040831
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2710
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Datex-Ohmeda, Inc.
- Date Received
- March 31, 2004
- Decision Date
- September 2, 2004
- Product Code
- DPZ
- 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 |
|---|---|---|---|
| DPZ | Oximeter, Ear | FDA class 2 | Cardiovascular |
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| K140575 | ENGSTROM CARESTATION, ENGSTROM PRO | Feb 3, 2015 | Substantially Equivalent |