Data / Medical devices / Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia (LPP): 9 FDA-registered makers in 6 countries
9 establishments in 6 countries are registered with the FDA to make Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia (product code LPP, Class 2, 21 CFR 868.2500). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on December 7, 2000, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LPP
- Device class
- 2
- Regulation
- 868.2500
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| Germany | 2 |
| Switzerland | 2 |
| Poland | 2 |
| Denmark | 1 |
| China | 1 |
| Sweden | 1 |
Makers of Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Radiometer Medical Aps | BROENSHOEJ Hovedstaden, Denmark | Complaint file establishment, Manufacturer | 1 | December 7, 2000 | 0 | 0 | 0 | api.fda.gov |
| Boyd Corporation GmbH | Syke Lower Saxony, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Aimooe Technology Co., Ltd. | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Perimed AB | JARFALLA Stockholm, Sweden | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medizin Systeme Boeblingen GmbH | BOEBLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Radiometer Basel AG | BASEL Basel-Stadt, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Radiometer Solutions Sp. z o.o. | Stargard Zachodniopomorskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Radiometer Sp. z o.o | Stargard Zachodniopomorskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sentec AG | THERWIL Basel-Landschaft, Switzerland | Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 7, 2000. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.