KEYBOARD FOR EPK-3000

KEYBOARD FOR EPK
N/A - OS-A94

A hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the functions of an endoscopic device (e.g., endoscope video camera) from a distance via a connected cable or wirelessly [e.g., radio-frequency (RF), infrared (IR) transmission]. It is intended to be operated by the healthcare provider.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PEA

Device Name: Endoscope, Accessories, Image Post-Processing For Color Enhancement

Device Class: 2

Physical State: The system consists of flexible and/or rigid scope(s), light source(s), video processor and display.

Definition: Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Image enhancement using image post-processing algorithms of the received white light image with the goal of enhancing visualization of suspicious images seen on white light.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Limited to endoscopic systems for observation of the gastro-urological tract.

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 04961333245284

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A