Adstation Oto-L/Coax+Oph-L,429, 9005W/Spec Disp, WB

Adstation Oto
Diagnostix™ - 56102L-349W

A collection of battery-powered devices intended to be used by a physician to perform an ophthalmic and/or otoscopic clinical examination on a patient. The devices are typically enclosed in a dedicated case and will typically include an ophthalmoscope and an otoscope, a dedicated interchangeable handle that contains the batteries which may be rechargeable and common to these examination devices, spare parts (e.g., extra ear specula, light bulbs) may include a line-powered charging station (e.g., desktop, wall-mounted) to house/charge these devices. This is a reusable device that may contain some disposable devices.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: FLL

Device Name: Thermometer, Electronic, Clinical

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 880.2910

Third Party Flag: Y

Medical Specialty: HO

Code: ERA

Device Name: Otoscope

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: EN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 874.4770

Third Party Flag: N

Medical Specialty: EN

Code: HLJ

Device Name: Ophthalmoscope, Battery-Powered

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: OP

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 886.1570

Third Party Flag: N

Medical Specialty: OP

Device Id: 00634782087784

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