FDA.reportPublic FDA data

NA

Primary DI
04582275250107
Brand
NA
Company
KONAN MEDICAL, INC.
Model
NSP
Published
2016-08-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HKICamera, ophthalmic, ac-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKICamera, Ophthalmic, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980357000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980357000KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETERKonan, Inc.1998-04-24HKI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04582275250107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582275250107045822752501074582275250107

GMDN Terms#

Term, Definition table
TermDefinition
Eye anterior segment analyserA mains electricity (AC-powered) ophthalmic instrument intended to be used to measure and evaluate various properties of the anterior segment (i.e., cornea, iris, pupil, anterior chamber and lens). It is typically used for corneal topography, pachymetry, pupillometry and three-dimensional (3-D) analysis of the anterior eye segment using, e.g., revolving dual-channel Scheimpflug photography (viewing of the anterior segment in a sagittal plane) and Placido imaging (involves a disk with concentric white and black rings). It is typically computerized and provides output to a computer, with installed dedicated application software; the software may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690768619
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582275250671NACellChek 20-1 PLUS2023-09-27
04582275250664NACellChek 20-12022-04-07
04582275250657NACC 20 rc2021-06-25
04582275250626NACellChek 202020-04-02
04582275250374NANSPC2016-09-23
04582275250404NACD-152016-09-23
04582275250428NACellchek2016-09-23
04582275250619N/APOM2017-11-27

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