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SPECTROS MEDICAL DEVICES INC

Matched from indexed company URL: SPECTROS CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30049572063004957206SPECTROS MEDICAL DEVICES INC1N2020-04-252211 Norfolk St #1110 Houston TX US 77098

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00851136007001Spectros T-Stat - 2.5 cm diameter surface probe for use with the T-Stat Monitor to measure ischemia.6508514040info@spectros.com
00851136007018Spectros T-Stat - 1 cm diameter surface sensor for use with the T-Stat Monitor to measure ischemia.6508514040info@spectros.com
00851136007025Spectros T-Stat - Endoscopic sensor for use with the T-Stat Monitor to measure ischemia650-851-4040info@spectros.com
00851136007032Spectros T-Stat - Gastrointestinal sensor for use with the T-Stat monitor to measure ischemia in colorectal tissue.6508514040info@spectros.com
00851136007049Spectros T-Stat - Oral sensor for use with the T-Stat Monitor to measure ischemia650-851-4040info@spectros.com
00851136007063Spectros T-Stat - The T-Stat 2.0 Microvascular Tissue Oximeter provides a continuous, non-invasive, and localized measurement of the microvascular hemoglobin oxygen saturation. sensitive to regional and global reduced flow or no-flow ischemia. It is intended for use as an adjunct monitor of the localized oxygen saturation of blood in microvasular tissue spaces.650-851-4040info@spectros.com
10851136007008Spectros T-Stat - 2.5 cm diameter surface probe for use with the T-Stat Monitor to measure ischemia.6508514040info@spectros.com
10851136007015Spectros T-Stat - 1 cm diameter surface sensor for use with the T-Stat Monitor to measure ischemia.6508514040info@spectros.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
633042060326010K192322T-Stat 2.0 Microvascular Tissue OximeterMUD2019-09-23
633041650809977K081233T-STAT 303 ISCHEMIA MONITORING SYSTEMMUD2008-07-28
633041779924869K040684T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303MUD2004-11-05

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MUD32019-09-23

PMN#

GUDID#