FDA.reportPublic FDA data

Mespere

Primary DI
M9831509000011
Brand
Mespere
Company
Mespere LifeSciences Inc
Model
OS-NeurOs
Published
2019-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MUDOximeter, Tissue Saturation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUDOximeter, Tissue SaturationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182242000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182242000VO200 – NeurOs Cerebral Oximetry SystemMespere Lifesciences, Inc.2018-12-26QEM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9831509000011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cerebral oximeterA mains electricity (AC-powered) photoelectric device that noninvasively measures the brain tissue blood oxygen saturation and venous oxygen saturation in the brain. It is typically used as an adjunct monitor for the regional haemoglobin oxygen saturation of blood in the brain of a paediatric or adult patient. It uses a cerebral sensor(s) having a light source and photodiode detector that is/are placed on the scalp/head. Position-1 detector detects infrared light absorption of extracranial blood and position-2 detector detects infrared light absorption of cerebral blood. Cerebral oxygenation is calculated by subtracting the absorption measured at site 1 from that measured at site 2.

Regulatory Flags#

DUNS number
203147665
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M9833340000101Mespere RH-012016-10-06
M9831101000041Mespere SEN-V20002016-10-06
M9831102000011Mespere DM-102016-10-06
M9831104000021Mespere DS-012016-10-06
M9831104000031Mespere MM-012016-10-06
M9831105000061Mespere PS-012016-10-06
M9831106000021Mespere IS-012016-10-06
M9831107000031Mespere SRA-V20002016-10-06
M9831108000021Mespere IFU-V20002016-10-06
M9831108000031Mespere QG-V20002016-10-06
M9831109000011Mespere OS-012016-10-06
M9831501000021Mespere SEN-NeurOs2019-01-28
M9831507000021Mespere SA-NeurOs2019-01-28

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Primary DI, Brand, Company table
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