THEOS MEDICAL SYSTEMS, INC.

FDA Device Registration & Listing · Santa Clara, CA, US · Registration 3008175374

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
3008175374
FEI Number
3008175374
Entity Name
THEOS MEDICAL SYSTEMS, INC.
City/State/Country
Santa Clara, CA, US
Establishment Address
2954 SCOTT BLVD, Santa Clara, CA 95054, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Theos Medical Systems, Inc. (Owner Number: 10031126)
Owner / Operator Contact Address
2954 Scott Blvd, Santa Clara, CA 95054, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ACE GUARDIAN SHIELD CHUMMIE NEWU ZEST SMART BLOOM

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KPN Alarm, Conditioned Response Enuresis Gastroenterology, Urology Class 2 876.2040 2009-12-22

Official Correspondent

Saket Bhatia

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Theos Medical Systems, 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
K780660 Nite Train-R Enterprises, Inc. NITE TRAIN'R 1978-07-28
K871787 Dilorenzo Engineering Co. ENURESIS ALARM 1987-08-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008175374. Last updated year: 2026. Please use registration number 3008175374 when referencing this establishment in official correspondence.
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