FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
ETCO2 Sensor
K Number: K171828
·
Decision May 31, 2018
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
304
Applicant Total
5
Review Days
345
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Basic Information
- Device Name
- ETCO2 Sensor
- K Number
- K171828
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1400
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orantech, Inc.
- Date Received
- June 20, 2017
- Decision Date
- May 31, 2018
- Product Code
- CCK
- Advisory Committee
- Anesthesiology
- 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 |
|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | FDA class 2 | Anesthesiology |
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Other Clearances by Orantech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K182327 | Patient Cables and Leadwires , Disposable ECG Leadwires | Jan 30, 2019 | Substantially Equivalent |
| K173194 | Temperature Probe | Oct 10, 2018 | Substantially Equivalent |
| K181270 | Disposable SpO2 Sensors, Reusable SpO2 Sensors | Sep 7, 2018 | Substantially Equivalent |
| K173197 | Reusable NIBP Cuff | Aug 21, 2018 | Substantially Equivalent |