FDA.reportPublic FDA data

FOGG SYSTEM COMPANY, INC.

Primary DI
00840416607451
Brand
FOGG SYSTEM COMPANY, INC.
Company
Fogg System Company, Inc.
Model
0346-2520
Device description
0346-2520 Interface Cable
Published
2026-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
00840416607451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840416607451008404166074518404166074510840416607451

Contacts#

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

Regulatory Flags#

DUNS number
058730946
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00840416607185FOGG SYSTEM COMPANY, INC.0460-2576:L722026-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00840416607413FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19