FDA.reportPublic FDA data

FOGG SYSTEM COMPANY, INC.

Primary DI
00840416606836
Brand
FOGG SYSTEM COMPANY, INC.
Company
Fogg System Company, Inc.
Model
0395-2403
Device description
0395-2403 Interface Cable
Published
2026-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222712000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222712000Fogg System Patient Monitoring CablesFogg System Company, Inc.2023-11-22DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840416606836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840416606836008404166068368404166068360840416606836

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(303)344-1883compliance@foggsystem.com

Regulatory Flags#

DUNS number
058730946
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840416606881FOGG SYSTEM COMPANY, INC.0432-2417:L802026-05-14
00840416606812FOGG SYSTEM COMPANY, INC.0178-22732026-04-30
00840416606829FOGG SYSTEM COMPANY, INC.0310-25412026-04-30
00840416606843FOGG SYSTEM COMPANY, INC.0395-22262026-04-30
00840416606850FOGG SYSTEM COMPANY, INC.0395-25182026-04-30
00840416606867FOGG SYSTEM COMPANY, INC.7382-00132026-04-30
00840416606874FOGG SYSTEM COMPANY, INC.0362-25942026-04-30
00840416606751FOGG SYSTEM COMPANY, INC.0346-19412026-04-15
00840416606768FOGG SYSTEM COMPANY, INC.0395-20542026-04-15
00840416606775FOGG SYSTEM COMPANY, INC.0395-24272026-04-15
00840416606782FOGG SYSTEM COMPANY, INC.7382-00112026-04-15
00840416606799FOGG SYSTEM COMPANY, INC.0360-19692026-04-15
00840416606805FOGG SYSTEM COMPANY, INC.0395-12362026-04-15
00840416606744FOGG SYSTEM COMPANY, INC.0431-24132026-04-01
00840416606676FOGG SYSTEM COMPANY, INC.0259-23572026-03-16
00840416606683FOGG SYSTEM COMPANY, INC.0407-24202026-03-16
00840416606690FOGG SYSTEM COMPANY, INC.0259-23602026-03-16
00840416606706FOGG SYSTEM COMPANY, INC.0346-24172026-03-16
00840416606713FOGG SYSTEM COMPANY, INC.0310-20252026-03-16
00840416606720FOGG SYSTEM COMPANY, INC.0396-24102026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08719689142209QMAPP Fysicon B.V.DSA2026-05-19
08719689142216QMAPP Fysicon B.V.DSA2026-05-19
08719689142223QMAPP Fysicon B.V.DSA2026-05-19
08719689142247QMAPP Fysicon B.V.DSA2026-05-19
08719689142254QMAPP Fysicon B.V.DSA2026-05-19
08719689142261QMAPP Fysicon B.V.DSA2026-05-19
08719689142322QMAPPFysicon B.V.DSA2026-05-19
08719689142339QMAPPFysicon B.V.DSA2026-05-19
08719689142346QMAPPFysicon B.V.DSA2026-05-19
08719689142353QMAPPFysicon B.V.DSA2026-05-19
08719689142360QMAPPFysicon B.V.DSA2026-05-19
08719689142377QMAPPFysicon B.V.DSA2026-05-19
08719689142384QMAPPFysicon B.V.DSA2026-05-19
08719689142391QMAPPFysicon B.V.DSA2026-05-19
08719689142407QMAPPFysicon B.V.DSA2026-05-19
08719689142414QMAPPFysicon B.V.DSA2026-05-19
08719689142469QMAPPFysicon B.V.DSA2026-05-19
08719689142476QMAPPFysicon B.V.DSA2026-05-19
08719689142483QMAPPFysicon B.V.DSA2026-05-19
08719689142490QMAPPFysicon B.V.DSA2026-05-19
08719689142506QMAPPFysicon B.V.DSA2026-05-19
08719689142513QMAPPFysicon B.V.DSA2026-05-19
08719689142520QMAPPFysicon B.V.DSA2026-05-19
08719689142537QMAPPFysicon B.V.DSA2026-05-19
08719689142544QMAPPFysicon B.V.DSA2026-05-19
08719689142551QMAPPFysicon B.V.DSA2026-05-19
08719689142568QMAPPFysicon B.V.DSA2026-05-19
08719689142575QMAPPFysicon B.V.DSA2026-05-19
08719689142582QMAPPFysicon B.V.DSA2026-05-19
08719689142599QMAPP Fysicon B.V.DSA2026-05-19