Duns Number:439770017
Device Description: The ESOTEST MULTI Adapter Cable is an accessory for the ESOTEST MULTI system that can b The ESOTEST MULTI Adapter Cable is an accessory for the ESOTEST MULTI system that can be inserted in a dedicated socket on the handle of the ESOTEST MULTI Patient Cable for connecting the conductive terminals of ESOTEST MULTI Probe to a mapping system.At one end, the adapter cable is equipped with a custom plug compatible with the dedicated port in the patient cable. The other end of the cable contains seven single pole polyurethane cables, each one ending in a 2mm touch-proof plug compatible with the input ports of a mapping system.
Catalog Number
F7817TPM70/30/US
Brand Name
ESOTEST MULTI ADAPTER CABLE
Version/Model Number
F7817TPM70/30/US
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K192210
Product Code
IKD
Product Code Name
Cable, Electrode
Public Device Record Key
9f22ebf9-cab9-4ced-bf72-2991bf7b3cd6
Public Version Date
December 13, 2019
Public Version Number
1
DI Record Publish Date
December 05, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 42 |