FDA.report

Onera STS 2

Primary DI
08720256698470
Brand
Onera STS 2
Company
Onera B.V.
Model
01.00
Catalog number
ONERA SLEEPMAP
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OLVStandard Polysomnograph With Electroencephalograph

Product Code Classifications

CodeDeviceSpecialtyClass
OLVStandard Polysomnograph With ElectroencephalographNeurology2

Premarket Submissions

SubmissionSupplement
K253668000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K253668000Onera SleepMap (SLEEPMAP)Onera B.V.2026-03-08OLZ

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08720256698470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08720256698470087202566984708720256698470

GMDN Terms

TermDefinition
Polysomnography analyserA mains electricity (AC-powered) device designed to record and interpret a variety of physiologic functions during sleep to evaluate sleep/sleep-related disorders (e.g., insomnia, hypersomnia, apnoea). It typically performs electroencephalography, electrocardiography, electro-oculography, electromyography, and respiration, temperature, and pulse oximetry readings. It may also provide audiovisual information about the sleeping patient for behavioral analysis and other measurements (e.g., gastric reflux, bedwetting). The device includes electrodes, measuring instruments, samplers, filters, amplifiers, and appropriate software for processing data and providing patient diagnoses.

Contacts

PhoneEmail
+310403082177info@onerahealth.com

Regulatory Flags

DUNS number
492293557
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08720256698005Onera STS01.00ONERA STS1 HEAD2023-03-15
08720256698012Onera STS01.00ONERA STS1 CHEST2023-03-15
08720256698029Onera STS01.00ONERA STS1 HEAD CRADLE2023-03-15
08720256698036Onera STS01.00ONERA STS1 LEG2023-03-15
08720256698043Onera STS01.00ONERA STS1 CHEST/LEG CRADLE2023-03-15
08720256698050Onera STS01.00ONERA STS1 FLOW2023-03-15
08720256698067Onera STS01.00ONERA STS1 FLOW CRADLE2023-03-15
08720256698074Onera STS01.00ONERA STS1 HEAD ADHESIVE C2023-03-15
08720256698098Onera STS01.00ONERA STS1 HEAD ADHESIVE B2023-03-15
08720256698111Onera STS01.00ONERA STS1 HEAD ADHESIVE A2023-03-15
08720256698135Onera STS01.00ONERA STS1 CHEST Adhesive2023-03-15
08720256698159Onera STS01.00ONERA STS1 LEG ADHESIVE2023-03-15
08720256698173Onera STS01.00ONERA STS1 FLOW ADHESIVE2023-03-15
08720256698197Onera STS01.00ONERA STS1 STATION SOFTWARE2023-03-15

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