Soft Flex-S ZP-200-51011

GUDID B675SOFTFLEXS1

Soft Flex Electrodes - Short

ZETO INC

Analytical scalp electrode, single-use
Primary Device IDB675SOFTFLEXS1
NIH Device Record Key4eed825a-4670-4170-aaa9-8e15e1991590
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoft Flex-S
Version Model NumberZP-200-51011
Catalog NumberZP-200-51011
Company DUNS079582566
Company NameZETO INC
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB675SOFTFLEXS0 [Unit of Use]
HIBCCB675SOFTFLEXS1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-28
Device Publish Date2019-10-18

Devices Manufactured by ZETO INC

B675DC0 - Zeto ONE Disinfection Container with Lid2024-11-28 The Zeto ONE Disinfection Container with Lid is an accessory of the Zeto ONE, which is an EEG system intended for prescription u
B675MM0 - Zeto All-in-One Medical Grade PC2024-11-28 The "Zeto All-in-One Medical Grade PC" is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in
B675ONEAUX1 - Zeto ONE AUX Cable Extension Set2024-06-19 The Zeto ONE AUX Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in he
B675ONEDU0 - Zeto ONE Display Unit2024-06-19 The Zeto ONE Display Unit (DU) is a part of the Zeto ONE, which is an EEG system intended for prescription use in healthcare fac
B675ONEECG1 - Zeto ONE ECG Cable Extension Set2024-06-19 The Zeto ONE ECG Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in he
B675ONEEMG1 - Zeto ONE EMG Cable Extension Set2024-06-19 The Zeto ONE EMG Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in he
B675ONEESB1 - Zeto ONE Electrode Set — Basic2024-06-19 The Zeto ONE Electrode Set — Basic is a part of the Zeto ONE, which is an EEG system intended for prescription use in a health
B675ONEHEOG1 - Zeto ONE HEOG Cable Extension Set2024-06-19 The Zeto ONE HEOG Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in h
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.