F2M20S8A F2M20S8A

GUDID 00894912002371

2 MHz flat CW Doppler probe.

KOVEN TECHNOLOGY, INC.

Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe
Primary Device ID00894912002371
NIH Device Record Keye30d888d-c473-4d77-8c8c-edcf85fc466d
Commercial Distribution Discontinuation2018-05-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameF2M20S8A
Version Model NumberF2M20S8A
Catalog NumberF2M20S8A
Company DUNS069261402
Company NameKOVEN TECHNOLOGY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100894912002371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOPTransducer, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2023-11-03
Device Publish Date2016-03-10

Devices Manufactured by KOVEN TECHNOLOGY, INC.

00894912002043 - BiDop 32023-11-03 Bidirectional Doppler with waveform display.
00894912002197 - PG-212023-11-03 PPG probe module.
00894912002203 - PGV-202023-11-03 PPG and Pulse Volume combo module for Smartdops.
00894912002296 - BF8M15S8A2023-11-03 8 MHz flat clinic CW Doppler probe.
00894912002302 - BT10M5S8A2023-11-03 10 MHz straight cable clinic CW Doppler probe.
00894912002319 - BT10M5S8C2023-11-03 10 MHz curly cable clinic CW Doppler probe.
00894912002333 - BT5M05S8A2023-11-03 5 MHz straight cable clinic CW Doppler probe.
00894912002340 - BT5M05S8C2023-11-03 5 MHz curly cable clinic CW Doppler probe.
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.