FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PULSE OXIMETER MODEL P10
K Number: K100225
·
Decision Feb 9, 2011
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
10
Review Days
379
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Basic Information
- Device Name
- PULSE OXIMETER MODEL P10
- K Number
- K100225
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mediana Co., Ltd.
- Date Received
- January 26, 2010
- Decision Date
- February 9, 2011
- 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 Mediana Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K200434 | V20, V20a, AVSM3 SNF | Oct 9, 2020 | Substantially Equivalent |
| K170497 | V10 | Dec 15, 2017 | Substantially Equivalent |
| K160358 | DT-100 | Feb 24, 2017 | Substantially Equivalent |
| K152659 | V10 | Aug 25, 2016 | Substantially Equivalent |
| K112190 | PATIENT MONITOR | Nov 9, 2011 | Substantially Equivalent |
| K110612 | FM20 | Nov 8, 2011 | Substantially Equivalent |
| K110630 | F10 | Jun 24, 2011 | Substantially Equivalent |
| K100217 | LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30 | Jun 8, 2010 | Substantially Equivalent |
| K051375 | VITAL SIGNS MONITOR | Jul 28, 2005 | Substantially Equivalent |