WESPER INC. LIC

FDA Device Registration & Listing · Long Island City, NY, US · Registration 3024722701

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
3024722701
FEI Number
3024722701
Entity Name
WESPER INC. LIC
City/State/Country
Long Island City, NY, US
Establishment Address
44-02 11th St., Ste 610, Long Island City, NY 11101, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Wesper Inc. (Owner Number: 10085957)
Owner / Operator Contact Address
234 5th Avenue, New York, NY 10001, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K191088
PMA Number
N/A

All Registered Proprietary Names

Wesper Lab Wesper Lab Oxiband (Checkme) O2 Pulse Oximeter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2023-03-23
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2022-09-22
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2022-09-22
DQA Oximeter Cardiovascular Class 2 870.2700 2022-09-22

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Wesper Inc.
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
K082968 Apneicare, LLC APNEICARE CONNECTION CENTER/INTERNET ANALYSIS 2009-01-02
K913749 Edentec Corp. EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 1992-07-02
K771407 Research Development Corp. LUNG VOLUME & PRESSURE MONITOR 1977-08-04
K122223 Philips Medizin Systeme Boeblingen GmbH NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO 2013-04-12
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-2022 NOX MEDICAL Keldnaholt Reykjavik Iceland 2
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024722701. Last updated year: 2026. Please use registration number 3024722701 when referencing this establishment in official correspondence.
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