EKLA CORPORATION

FDA Device Registration & Listing · Naperville, IL, US · Registration 3008733163

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
3008733163
FEI Number
3008733163
Entity Name
EKLA CORPORATION
City/State/Country
Naperville, IL, US
Establishment Address
1707 Quincy Ave Ste 127, Naperville, IL 60540, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
EKLA Corporation (Owner Number: 10035863)
Owner / Operator Contact Address
1707 Quincy Ave. Suite 127, Naperville, IL 60540, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

EKLA FINGER PULSE OXIMETER, E02-1001 NOVAPLUS FINGER PULSE OXIMETER, V02-1001 EKLA Infrared Forehead Thermometer; EDTT-1B, VDTT-1B EKLA Push Button Blood Collection FPA Set, administration, intravascular EKLA 500cc Pressure Infusion Bag with mesh back EKLA 1000cc Pressure Infusion Bag with mesh back EKLA 3000cc Pressure Infusion Bag with clear back EKLA 500cc Pressure Infusion Bag with clear back EKLA 3000cc Pressure Infusion Bag with mesh back EKLA 1000cc Pressure Infusion Bag with clear back

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQA Oximeter Cardiovascular Class 2 870.2700 2021-01-21
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-08-05
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-08-08
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2025-08-08
KZD Infusor, Pressure, For I.V. Bags General Hospital Class 1 880.5420 2023-05-01

Official Correspondent

Erin Lu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EKLA Corporation
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 3008733163. Last updated year: 2026. Please use registration number 3008733163 when referencing this establishment in official correspondence.
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