FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PICOSAT II SPO2 PULSE OXIMETRY MODULE
K Number: K030973
·
Decision Jul 23, 2003
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
107
Review Days
117
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Basic Information
- Device Name
- PICOSAT II SPO2 PULSE OXIMETRY MODULE
- K Number
- K030973
- 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
- Date Received
- March 28, 2003
- Decision Date
- July 23, 2003
- 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)
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Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
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Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
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AViTA Pulse Oximeter (SP61)
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YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
FDA 510(k)
FDA Class 2
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