FDA.reportPublic FDA data

Compumedics Falcon

Primary DI
09342451002754
Brand
Compumedics Falcon
Company
COMPUMEDICS LIMITED
Model
Falcon HST
Catalog number
8036-0003-01
Device description
Falcon HST Cradle
Published
2026-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNRVentilatory Effort Recorder
OLVStandard Polysomnograph With Electroencephalograph
OMCReduced- Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNRVentilatory Effort RecorderAnesthesiology2
OLVStandard Polysomnograph With ElectroencephalographNeurology2
OMCReduced- Montage Standard ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242447000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242447000Falcon HSTCompumedics Limited2025-02-20OLV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09342451002754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09342451002754093424510027549342451002754

GMDN Terms#

Term, Definition table
TermDefinition
PolysomnographA mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+61384207386support@compumedics.com.au
1-877-294-1346support@compumedicsusa.com

Regulatory Flags#

DUNS number
753750967
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09342451002433Compumedics CurryCURRY 98238-0044-012026-03-12
09342451002655Compumedics SomfitSomfit8037-0001-002026-03-12
09342451002662Compumedics SomfitSomfit Charger8037-0101-002026-03-12
09342451002747Compumedics FalconFalcon HST8036-0002-022026-03-12
09342451002785Compumedics FalconFalcon HST9036-0001-022026-03-12
09342451002822Compumedics SomfitSomfit9037-0003-002026-03-12
09342451002860Compumedics SomfitSomfit9037-0013-002026-03-12
09342451003416Compumedics Quik-GelQuik-Gel Electrolyte920000172026-03-12
09342451003423Compumedics Quik-GelQuik-Gel Electrolyte920000162026-03-12
09342451003430Compumedics Quik-GelQuik-Gel Electrolyte920000152026-03-12
09342451003447Compumedics Quik-GelQuik-Gel Electrolyte920000142026-03-12
09342451007063Compumedics Somfit DSomfit D9037-0022-002026-03-12
09342451004772Compumedics Quik-CapQuik-Cap Neoprene Flexnet - SynAmps 2/RT 128 Ch La8035-0007-012026-03-03
09342451003904Compumedics Quik-CapQuik-Cap Hydrocell Array - SynAmps 2/RT 64 Ch Medi8035-0164-012026-03-02
09342451003980Compumedics Quik-CapQuik-Cap Neoprene Flexnet - Grael 128 Ch Medium8035-0154-012026-03-02
09342451003997Compumedics Quik-CapQuik-Cap Neoprene Flexnet - Grael 64 Ch Medium8035-0153-012026-03-02
09342451004000Compumedics Quik-CapQuik-Cap Neoprene Flexnet - SynAmps 2/RT 256 Ch Me8035-0151-012026-03-02
09342451004017Compumedics Quik-CapQuik-Cap Neoprene Flexnet - SynAmps 2/RT 128 Ch Me8035-0150-012026-03-02
09342451004024Compumedics Quik-CapQuik-Cap Neoprene Flexnet - SynAmps 2/RT 64 Ch Med8035-0149-012026-03-02
09342451004031Compumedics Quik-CapQuik-Cap Neoprene Flexnet - SynAmps 2/RT 32 Ch Med8035-0148-012026-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08885021950013TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08885021950136TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08720256698296Onera STS 2Onera B.V.MNR2026-05-15
08720256698296Onera STS 2Onera B.V.OLV2026-05-15
08720256698302Onera STS 2Onera B.V.OLV2026-05-15
08720256698302Onera STS 2Onera B.V.MNR2026-05-15
08720256698319Onera STS 2Onera B.V.MNR2026-05-15
08720256698319Onera STS 2Onera B.V.OLV2026-05-15
08720256698326Onera STS 2Onera B.V.MNR2026-05-15
08720256698326Onera STS 2Onera B.V.OLV2026-05-15
08720256698333Onera STS 2Onera B.V.OLV2026-05-15
08720256698333Onera STS 2Onera B.V.MNR2026-05-15
08720256698340Onera STS 2Onera B.V.OLV2026-05-15
08720256698340Onera STS 2Onera B.V.MNR2026-05-15
08720256698357Onera STS 2Onera B.V.MNR2026-05-15
08720256698357Onera STS 2Onera B.V.OLV2026-05-15
08720256698364Onera STS 2Onera B.V.MNR2026-05-15
08720256698364Onera STS 2Onera B.V.OLV2026-05-15
08720256698371Onera STS 2Onera B.V.OLV2026-05-15
08720256698371Onera STS 2Onera B.V.MNR2026-05-15
08720256698463Onera STSOnera B.V.MNR2026-05-15
08720256698463Onera STSOnera B.V.OLV2026-05-15
08720256698487Onera STSOnera B.V.MNR2026-05-15
08720256698487Onera STSOnera B.V.OLV2026-05-15
08720256698494Onera STSOnera B.V.MNR2026-05-15
08720256698494Onera STSOnera B.V.OLV2026-05-15
08720256698500Onera STSOnera B.V.MNR2026-05-15
08720256698500Onera STSOnera B.V.OLV2026-05-15
08720256698517Onera STSOnera B.V.MNR2026-05-15
08720256698517Onera STSOnera B.V.OLV2026-05-15