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FDA Browser
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Innolitics
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Diagnostic Devices
CFR Sub-Part
HKX
Tonometer, Ac-Powered
2
Product Code
K
19
0382
Intraocular Pressure Tonometer EASYTON
2
Cleared 510(K)
Show All 56 Submissions
Orthopedic
Review Panel
Pathology
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Physical Medicine
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Radiology
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General and Plastic Surgery
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Toxicology
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Unknown
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Last synced on 24 March 2023 at 11:04 pm
OP
/
diagnostic-devices
/
HKX
/
K190382
View Source
Intraocular Pressure Tonometer EASYTON
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190382
510(k) Type
Traditional
Applicant
Company Elamed
Country
Russia
FDA Decision
Substantially Equivalent
Decision Date
12/6/2019
Days to Decision
290 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Diagnostic Devices
HKX
Tonometer, Ac-Powered
K
19
0382
Intraocular Pressure Tonometer EASYTON
Show All 56 Submissions
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OP
/
diagnostic-devices
/
HKX
/
K190382
View Source
Intraocular Pressure Tonometer EASYTON
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190382
510(k) Type
Traditional
Applicant
Company Elamed
Country
Russia
FDA Decision
Substantially Equivalent
Decision Date
12/6/2019
Days to Decision
290 days
Submission Type
Summary