FDA.reportPublic FDA data

FOGG SYSTEM COMPANY, INC.

Primary DI
00840416606829
Brand
FOGG SYSTEM COMPANY, INC.
Company
Fogg System Company, Inc.
Model
0310-2541
Device description
0310-2541 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
00840416606829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840416606829008404166068298404166068290840416606829

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
00840416607451FOGG SYSTEM COMPANY, INC.0346-25202026-11-02
00840416607468FOGG SYSTEM COMPANY, INC.0310-2586:L722026-11-02
00840416607475FOGG SYSTEM COMPANY, INC.0310-24092026-11-02
00840416607482FOGG SYSTEM COMPANY, INC.0395-25462026-11-02
00840416607406FOGG SYSTEM COMPANY, INC.0430-22632026-10-19
00840416607413FOGG SYSTEM COMPANY, INC.0464-2575:L602026-10-19
00840416607420FOGG SYSTEM COMPANY, INC.0408-23512026-10-19
00840416607437FOGG SYSTEM COMPANY, INC.0468-25862026-10-19
00840416607444FOGG SYSTEM COMPANY, INC.0408-24992026-10-19
00840416607345FOGG SYSTEM COMPANY, INC.0231-2575:L722026-10-05
00840416607352FOGG SYSTEM COMPANY, INC.0264-2575:L722026-10-05
00840416607369FOGG SYSTEM COMPANY, INC.0259-21662026-10-05
00840416607376FOGG SYSTEM COMPANY, INC.0395-24102026-10-05
00840416607383FOGG SYSTEM COMPANY, INC.0458-24502026-10-05
00840416607390FOGG SYSTEM COMPANY, INC.0264-24502026-10-05
00840416607130FOGG SYSTEM COMPANY, INC.0437-2474:L722026-08-17
00840416607147FOGG SYSTEM COMPANY, INC.0310-21102026-08-17
00840416607154FOGG SYSTEM COMPANY, INC.0464-25902026-08-17
00840416607161FOGG SYSTEM COMPANY, INC.0346-2291:L842026-08-17
00840416607178FOGG SYSTEM COMPANY, INC.0395-2352-2320:L102026-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840416607451FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-11-02
00840416607468FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-11-02
00840416607475FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-11-02
00840416607482FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-11-02
06944413830585ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830592ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830608ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830615ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830622ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830639ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830646ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830653ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830660ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830677ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830684ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830691ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830707ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830714ECG CableEdan Instruments, Inc.DSA2026-11-02
G662ME550W1MaguireMaguire Enterprises, Inc.DSA2026-10-30
G662ME590028G1MaguireMaguire Enterprises, Inc.DSA2026-10-30
G662ME590028J1MaguireMaguire Enterprises, Inc.DSA2026-10-30
00191506063191OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDSA2026-10-28
04719872982296QT ECGQt Medical, Inc.DSA2026-10-28
04719872982302QT ECGQt Medical, Inc.DSA2026-10-28
04719872982418QT ECGQt Medical, Inc.DSA2026-10-28
06946725572924APKAPK Technology Co.,Ltd.DSA2026-10-26
00884838085299Dual IBP AdapterPhilips Medizin Systeme Böblingen GmbHDSA2026-10-21
G662ME361G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
G662ME368G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
00840416607406FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19