Data / Medical devices / Israel / S.L.P. Ltd.
S.L.P. Ltd.: FDA-registered device maker in Tel-Aviv Tel Aviv, Israel, 4 510(k) clearances
S.L.P. Ltd. is registered with the FDA (registration 9614500) in Tel-Aviv Tel Aviv, Israel. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 9, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9614500
- FEI number
- 3000225562
- Address
- 62 Anilevitz St., Tel-Aviv Tel Aviv, Israel, 6706016
- Owner or operator
- S.L.P. LTD. (9011043)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- January 7, 2002
- Registered through
- 2026
- Brand names listed
- Accessory to tranducer gas pressure, Cables, Electrodes, OxSAT100, SLEEPSENSE®, Sleep Disorder sensors, SleepSense
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Repackager or relabeler | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Transducer, Gas Pressure | BXO | 1 | Exporter to the US | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 9, 2020 | K191574 | OxSAT 100 | DQA | Substantially Equivalent | S.L.P. , Ltd. | accessdata.fda.gov |
| October 7, 2010 | K100077 | NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103 | DQA | Substantially Equivalent | Solaris Medical Technology, Inc. | accessdata.fda.gov |
| April 3, 2009 | K082846 | APK SPO2 PULSE OXIMETER SENSOR | DQA | Substantially Equivalent | APK Technology Co., Ltd. | accessdata.fda.gov |
| October 6, 2004 | K042253 | SLEEPSENSE SLEEP SENSORS | MNR | Substantially Equivalent | S.L.P. , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Gas Pressure
- All makers of Ventilatory Effort Recorder
- All makers of Cable, Electrode
- All makers of Oximeter
Updated April 9, 2020. 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.