FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A
K Number: K042306
·
Decision Oct 15, 2004
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
48
Review Days
51
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Basic Information
- Device Name
- PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A
- K Number
- K042306
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Medizin Systeme Boeblingen GmbH
- Date Received
- August 25, 2004
- Decision Date
- October 15, 2004
- 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.
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| K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X) | Sep 30, 2021 | Substantially Equivalent |
| K192137 | IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 | Sep 11, 2020 | Substantially Equivalent |
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