Siesta

Primary DI
09342451002112
Brand
Siesta
Company
Compumedics Usa, Inc.
Model
Siesta 802 Basic EEG System
Catalog number
9007-0061-01
Device description
Siesta 802 Basic EEG System w/o Software
Published
2020-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GWQFull-Montage Standard Electroencephalograph
OLVStandard Polysomnograph With Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2
OLVStandard Polysomnograph With ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003175000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003175000COMPUMEDICS SIESTA SYSTEMCompumedics Limited2000-12-27OLV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09342451002112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09342451002112093424510021129342451002112

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic ambulatory recorderAn electrically-powered device designed for 24-hour recording of electroencephalographic signals in ambulatory patients for periods usually from 24 to 72 hours to assess a variety of neurological conditions (e.g., epilepsy) and psychiatric disorders. It typically includes a small cassette tape recorder or a digital medium (no moving parts) with appropriate signal amplifiers worn by the patient, and a set of scalp electrodes that are placed on the cranium of the patient. The resulting electroencephalogram (EEG) is typically analysed in an electroencephalographic analyser.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
111312307
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09342451001788SiestaSiesta 802 Basic PSG System9007-0060-002020-12-15

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