SPECTROS MEDICAL DEVICES INC

FDA Device Registration & Listing · Houston, TX, US · Registration 3004957206

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
3004957206
FEI Number
3004957206
Entity Name
SPECTROS MEDICAL DEVICES INC
City/State/Country
Houston, TX, US
Establishment Address
2211 Norfolk St #1110, Houston, TX 77098, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Spectros Medical Devices Inc (Owner Number: 9062042)
Owner / Operator Contact Address
2211 Norflolk St #1110, Houston, TX 77098, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K192322
PMA Number
N/A

All Registered Proprietary Names

T-stat T-stat T-stat T-stat

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FOX Stand, Infusion General Hospital Class 1 880.6990 2024-05-24
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2007-12-17
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2009-11-18
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2019-10-16

Official Correspondent

Ashley Dynan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Spectros Medical Devices 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
K201432 Masimo Corporation Masimo O3 Regional Oximeter System 2020-08-29
K211561 Covidien, LLC INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) 2021-12-05

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004957206. Last updated year: 2026. Please use registration number 3004957206 when referencing this establishment in official correspondence.
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