S.L.P. LTD.

FDA Device Registration & Listing · Tel-Aviv Tel Aviv, IL · Registration 9614500

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9614500
FEI Number
3000225562
Entity Name
S.L.P. LTD.
City/State/Country
Tel-Aviv Tel Aviv, IL
Establishment Address
62 Anilevitz St., Tel-Aviv Tel Aviv 6706016, IL
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
S.L.P. LTD. (Owner Number: 9011043)
Owner / Operator Contact Address
62 Anilevitz St., --, Tel-Aviv, IL-TA 6706016, IL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K100077
PMA Number
N/A

All Registered Proprietary Names

Cables, Electrodes OxSAT100 Accessory to tranducer gas pressure SLEEPSENSE® Sleep Disorder sensors SleepSense

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2007-03-28
DQA Oximeter Cardiovascular Class 2 870.2700 2023-01-30
BXO Transducer, Gas Pressure Anesthesiology Class 1 868.2900 2010-09-14
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2002-01-07
DQA Oximeter Cardiovascular Class 2 870.2700 2016-05-10

Official Correspondent

Gabriel Salmon

US Agent Details

Sarah Paddock Business: S.L.P. INC. Email: Sara@sleepsense.com Phone: (630) 5137479

Related Public Records

Same Entity

S.L.P. LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23
K973147 Nellcor Puritan Bennett, Inc. NPB-295 PULSE OXIMETER 1997-11-14
K231243 Guangdong Genial Technology Co., Ltd. Finger Clip Pulse Oximeter 2023-10-31
K971628 Somanetics Corp. SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) 1997-10-10
K153184 Shenzhen Caremed Medical Technology Co., Ltd. Caremed Reusable & Disposable SPO2 Sensors 2017-01-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614500. Last updated year: 2026. Please use registration number 9614500 when referencing this establishment in official correspondence.
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