FDA.reportPublic FDA data

Simplified Sleep Stage Evaluation for SOMNOtouch RESP

Primary DI
04250413404056
Brand
Simplified Sleep Stage Evaluation for SOMNOtouch RESP
Company
SOMNOmedics AG
Model
TOS051
Published
2019-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140861000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140861000SOMNOTOUCH RESPSomnomedics GmbH2015-01-30MNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250413404056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250413404056042504134040564250413404056

GMDN Terms#

Term, Definition table
TermDefinition
PolygraphA multichannel physiologic graphic recorder designed for the simultaneous recording of a number of different physiologic parameters, e.g., electrocardiogram (ECG), blood pressure, electroencephalogram (EEG), temperature or respiration. This device is frequently used for testing the truth of a person's statements (i.e., used as a "lie detector").

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314112173
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250413402748SOMNOwatch plus ACTISOWP100Z2023-12-07
04250413402755SOMNOwatch plus ACTISOWP200Z2023-12-07
04250413401475SOMNOwatch plus ACTISOWP2002019-04-12
04250413401666SOMNOwatch plus Docking StationSOW1062019-04-12
04250413410705Set for wireless PLM measurementNGA1132019-08-13
042504134107121 channel ECG sensor including body position and disposable electrodesNGS091S2019-08-13
04250413405640ABPM pro basic deviceABP050U2024-05-08
04250413410781SOMNO HD / ECO accessoryNGA3102023-11-30
04250413410828SOMNOscreen ECO EEG 32NGN740U 2023-11-30
04250413410835SOMNOtouch RESP accessoryTOS110S2023-11-30
04250413410842SOMNOtouch RESP accessoryTOS175S2023-11-30
04250413410859SOMNOtouch RESP accessoryTOS011S2023-11-30
04250413400522SOMNOscreen Plus accessorySEN614O2023-08-25
04250413400607SOMNOscreen Plus accessorySEN6132023-08-25
04250413400614SOMNOscreen Plus accessorySEN6142023-08-25
00833166000405SOMNOscreen plus AccessorySEN2092017-05-22
00833166000412SOMNOscreen plus AccessorySEN2152017-05-22
04250413400362Microphone for Snoring detectionSEN6022019-04-12
04250413400386Activity Sensor for Sleep/Wake detectionSEN6202019-04-12
042504134004161-channel ECG ElectrodeSEN6272019-04-12