Micromed - LED PHOTIC POWER is the power supply adapter - MICROMED SPA

Duns Number:856998166

Device Description: LED PHOTIC POWER is the power supply adapter included in LED PHOTIC System. LED PHOTIC Sys LED PHOTIC POWER is the power supply adapter included in LED PHOTIC System. LED PHOTIC System is used for the photic stimulation of the patient during the EEG recording

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More Product Details

Catalog Number

-

Brand Name

Micromed

Version/Model Number

LED PHOTIC POWER

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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

K211974

Product Code Details

Product Code

GWE

Product Code Name

Stimulator, Photic, Evoked Response

Device Record Status

Public Device Record Key

02d8d5a7-c027-434f-b6f5-6d2162bec8f7

Public Version Date

November 02, 2021

Public Version Number

1

DI Record Publish Date

October 25, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MICROMED SPA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 12