FDA.reportPublic FDA data

Compumedics Somfit

Primary DI
09342451002822
Brand
Compumedics Somfit
Company
COMPUMEDICS LIMITED
Model
Somfit
Catalog number
9037-0003-00
Device description
Somfit System Americas
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
OMCReduced- Montage Standard Electroencephalograph

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231546000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231546000SomfitCompumedics Limited2023-11-30MNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09342451002822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09342451002822093424510028229342451002822

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
09342451002754Compumedics FalconFalcon HST8036-0003-012026-03-12
09342451002785Compumedics FalconFalcon HST9036-0001-022026-03-12
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

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04250413402380Pneumatic Effort Belt - Size XSSOMNOmedics AGMNR2026-10-09
04250413402397Pneumatic Effort Belt - Size SSOMNOmedics AGMNR2026-10-09
04250413402403Pneumatic Effort Belt - Size MSOMNOmedics AGMNR2026-10-09
04250413402410Pneumatic Effort Belt - Size LSOMNOmedics AGMNR2026-10-09
04250413402427Pneumatic Effort Belt - Size XXLSOMNOmedics AGMNR2026-10-09
04250413410392Wireless PLM/EMG sensor right legSOMNOmedics AGMNR2026-10-08
04250413401635DOMINO lightSOMNOmedics AGMNR2026-10-07
04250413402861EEG-ElectrodeSOMNOmedics AGMNR2026-10-07
04250413404858SOMNOtouch™ RESP ecoSOMNOmedics AGMNR2026-10-07
04250413405664DOMINOSOMNOmedics AGMNR2026-10-07
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