FDA.reportPublic FDA data

micromed

Primary DI
08033928120736
Brand
micromed
Company
MICROMED SPA
Model
SD LTM 32 EXPRESS
Device description
fixed and/or ambulatory long-term EEG recorder, 32 EEG channels
Published
2018-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OLVStandard Polysomnograph With Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLVStandard Polysomnograph With ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071782000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071782000MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICESMicromed S.P.A.2008-01-10OLV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033928120736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033928120736080339281207368033928120736

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, electroencephalographicA small unit dedicated to detect and record the electrical activity of the brain in the form of an electroencephalogram (EEG). The electrical activity of the brain is detected via electrodes affixed to the patient's forehead or scalp. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which operates as a mainframe computer displaying the signals measured and provided by this module. It may also register auditory evoked potentials (AEP) signals.

Regulatory Flags#

DUNS number
856998166
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033928120910micromedBRAIN QUICK2018-03-21
08033928121184MicromedLED PHOTIC2021-10-25
08033928121207MicromedLED PHOTIC POWER2021-10-25
08033928120880micromedSystemPlus EVOLUTION2018-03-21
08033928120958MicromedBRAIN QUICK SOFTWARE2018-05-21
08033928120828MicromedSD LTM STIM2018-07-02
08033928120743micromedBRAIN SPY PLUS2018-03-21
08033928120750micromedSD LTM 64 EXPRESS2018-03-21
08033928120798micromedMORPHEUS2018-03-21
08033928120897MicromedSD LTM 64 PLUS2018-05-21
08033928120903MicromedSD LTM 32 PLUS2018-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720256698296Onera STS 2Onera B.V.OLV2026-05-15
08720256698302Onera STS 2Onera B.V.OLV2026-05-15
08720256698319Onera STS 2Onera B.V.OLV2026-05-15
08720256698326Onera STS 2Onera B.V.OLV2026-05-15
08720256698333Onera STS 2Onera B.V.OLV2026-05-15
08720256698340Onera STS 2Onera B.V.OLV2026-05-15
08720256698357Onera STS 2Onera B.V.OLV2026-05-15
08720256698364Onera STS 2Onera B.V.OLV2026-05-15
08720256698371Onera STS 2Onera B.V.OLV2026-05-15
08720256698463Onera STSOnera B.V.OLV2026-05-15
08720256698487Onera STSOnera B.V.OLV2026-05-15
08720256698494Onera STSOnera B.V.OLV2026-05-15
08720256698500Onera STSOnera B.V.OLV2026-05-15
08720256698517Onera STSOnera B.V.OLV2026-05-15
08720256698524Onera STSOnera B.V.OLV2026-05-15
08720256698531Onera STSOnera B.V.OLV2026-05-15
00850049266055WavebandBeacon Biosignals, Inc.OLV2026-04-17
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09342451002754Compumedics FalconCOMPUMEDICS LIMITEDOLV2026-03-12
00840067104224CadwellCADWELL INDUSTRIES, INC.OLV2026-03-02
00840067104217CadwellCADWELL INDUSTRIES, INC.OLV2026-03-01
00850063034364Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2025-12-22
00817111021332PolysmithNeurotronics, LLCOLV2025-09-23
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00850063034142Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.OLV2025-01-28
00850063034159Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.OLV2025-01-28