FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03
K Number: K062268
·
Decision Oct 18, 2006
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
24
Review Days
72
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03
- K Number
- K062268
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Medical Systems North America Co.
- Date Received
- August 7, 2006
- Decision Date
- October 18, 2006
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQA), ordered by most recent decision date.
Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
FDA 510(k)
FDA Class 2
·Cardiovascular
Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
FDA 510(k)
FDA Class 2
·Cardiovascular
Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
FDA 510(k)
FDA Class 2
·Cardiovascular
Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
FDA 510(k)
FDA Class 2
·Cardiovascular
AViTA Pulse Oximeter (SP61)
FDA 510(k)
FDA Class 2
·Cardiovascular
YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Philips Medical Systems North America Co.
| K Number | Device Name | ||
|---|---|---|---|
| K101311 | EP NAVIGATOR R3 | Sep 30, 2010 | Substantially Equivalent |
| K090625 | WIRELESS PORTABLE DETECTOR FD-W17 | Mar 24, 2009 | Substantially Equivalent |
| K090590 | VERADIUS, MODEL 718-130 | Mar 16, 2009 | Substantially Equivalent |
| K082280 | SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR | Oct 8, 2008 | Substantially Equivalent |
| K063781 | PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE | Jan 5, 2007 | Substantially Equivalent |
| K061685 | PULSERA | Sep 15, 2006 | Substantially Equivalent |
| K061995 | XCELERA | Sep 6, 2006 | Substantially Equivalent |
| K060749 | XPERCT | Apr 4, 2006 | Substantially Equivalent |
| K050692 | FLXIS | Apr 8, 2005 | Substantially Equivalent |
| K043147 | ACHIEVA FAMILY | Feb 15, 2005 | Substantially Equivalent |