Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
This cutaneous oxygen monitor is a non-invasive device that measures the partial pressure of oxygen diffusing through the skin (transcutaneous oxygen tension), used for monitoring oxygenation in patients other than infants not under gas anesthesia, including in vascular and critical care settings. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification. The product code is LPP, regulated under 21 CFR 868.2500, within the Anesthesiology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LPP
- Device Class
- FDA class 2
- Regulation Number
- 868.2500
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.