Freespira, Inc

FDA Device Registration & Listing · Kirkland, WA, US · Registration 3010887638

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
3010887638
FEI Number
3010887638
Entity Name
Freespira, Inc
City/State/Country
Kirkland, WA, US
Establishment Address
12020 113th Ave NE, Ste 215, Kirkland, WA 98034, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Remanufacture Medical Device,Manufacture Medical Device
Owner / Operator
Palo Alto Health Sciences (Owner Number: 10046775)
Owner / Operator Contact Address
12020 113th Ave NE, 068023986Ste 215, Kirkland, WA 98034, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K180173
PMA Number
N/A

All Registered Proprietary Names

Freespira

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HCC Device, Biofeedback Neurology Class 2 882.5050 2018-12-17
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2018-12-17

Official Correspondent

Simon Thomas

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Palo Alto Health Sciences
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
K873418 Bodylog, Inc. BODYLOG STRESS REDUCTION PACKAGE 1987-12-17
K792659 Bio-Feedback Systems, Inc. FEEDBACK EDR SYSTEM MODEL ME-1 1980-01-09
K142467 Abeon Medical Corporation IntelAir Nasal Airway Support System 2014-11-24
K861213 Datex Division Instrumentarium Corp. PB 254 IR - SPECTROMETER 1986-04-04
K172904 Philips Medizin Systeme Boeblingen GmbH IntelliVue Capnography Extension, IntelliVue Microstream Extension 2017-12-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0021-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010887638. Last updated year: 2026. Please use registration number 3010887638 when referencing this establishment in official correspondence.
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