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FDA 510(k), K190382, Intraocular Pressure Tonometer EASYTON
FDA 510(k), K190382, Intraocular Pressure Tonometer EASYTON
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510(K) Number: K190382
Device Name: Intraocular Pressure Tonometer EASYTON
Manufacturer: Company Elamed
Device Classification Name: tonometer, ac-powered
Regulation Number: 886.1930
Classification Product Code: HKX
Date Received: 02/19/2019
Decision Date: 12/06/2019
Regulation Medical Specialty: Ophthalmic
Device Name: Intraocular Pressure Tonometer EASYTON
Manufacturer: Company Elamed
Device Classification Name: tonometer, ac-powered
Regulation Number: 886.1930
Classification Product Code: HKX
Date Received: 02/19/2019
Decision Date: 12/06/2019
Regulation Medical Specialty: Ophthalmic
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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