Icare ic200

GUDID 06430033851036

The Icare ic200 (TA031) tonometer is a hand-held, battery operated device, which measures intraocular pressure (IOP) without the need for topical anesthesia. The Icare ic200 tonometer measures the IOP by utilizing the rebound method. The Icare ic200 tonometer is intended to be used for the measurement of intraocular pressure of the human eye. Icare ic200 allows IOP measurement of patients in all positions between sitting and supine positions. IOP measurement result can be transferred to printer or to a PC via Bluetooth connection.

ICARE FINLAND OY

Ophthalmic tonometer, battery-operated
Primary Device ID06430033851036
NIH Device Record Key385b0c2f-6aef-4469-9264-e6d57d5075ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameIcare ic200
Version Model NumberTA031
Company DUNS651755092
Company NameICARE FINLAND OY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106430033851036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HKYTonometer, Manual

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-27
Device Publish Date2020-01-17

On-Brand Devices [Icare ic200]

06430033851036The Icare ic200 (TA031) tonometer is a hand-held, battery operated device, which measures intrao
06430033851463iCare IC200 (with Quick Measure feature)
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