COGNITA LABS LLC

FDA Device Registration & Listing · Santa Ana, CA, US · Registration 3017200972

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
3017200972
FEI Number
3017200972
Entity Name
COGNITA LABS LLC
City/State/Country
Santa Ana, CA, US
Establishment Address
700 N MAIN ST, STE C1, Santa Ana, CA 92701, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Cognita Labs LLC (Owner Number: 10076939)
Owner / Operator Contact Address
700 N MAIN ST, STE C1, Santa Ana, CA 92701, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K183586
PMA Number
N/A

All Registered Proprietary Names

PulmoScan CapMedic

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PNV Impedance Measuring Device Utilizing Oscillation Techniques Anesthesiology Class 2 868.1840 2020-08-05
BZK Spirometer, Monitoring (W/Wo Alarm) Anesthesiology Class 2 868.1850 2020-08-05
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2020-08-05

Official Correspondent

Gaurav Patel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cognita Labs LLC
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
K163485 Adherium (Nz), Ltd. SmartTouch 2017-08-30
K781467 Travenol Laboratories, S.A. U-FLOAT VALVE 2D9023 1978-09-07

Similar Registrations

Registration Number Establishment Name Location
3011331794 THORASYS THORACIC MEDICAL SYSTEMS INC. Montreal Quebec, CA
3012624216 RESTECH SRL Milano, IT
3006783791 GaleMed (Xiamen) Co., Ltd. XIAMEN Fujian, CN
1219324 RESPIRONICS NOVAMETRIX, LLC Andover, MA, US
3004415070 KB Components Finland Oy Nurmijarvi Etela-Karjala, FI
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017200972. Last updated year: 2026. Please use registration number 3017200972 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.