Fundus Camera

GUDID 06973211070602

It is an AC-powered device intended to take photographs of the fundus of eye

CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD

Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera
Primary Device ID06973211070602
NIH Device Record Keybf2a12e9-b115-4dcc-9a75-a08a9077dff1
Commercial Distribution StatusIn Commercial Distribution
Brand NameFundus Camera
Version Model NumberSK-650A
Company DUNS545824560
Company NameCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106973211070602 [Primary]

FDA Product Code

PJZCamera, Ophthalmic, General-Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-10
Device Publish Date2020-07-02

On-Brand Devices [Fundus Camera]

06973211070626It is an AC-powered device intended to take photographs of the fundus of eye
06973211070602It is an AC-powered device intended to take photographs of the fundus of eye
06973211070008This equipment adopts advanced opto-mechanical and electrical integration technology, and integr

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.