FDA 510(k), K181143, Keeler TonoCare Tonometer

FDA 510(k), K181143, Keeler TonoCare Tonometer

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510(K) Number: K181143
Device Name: Keeler TonoCare Tonometer
Manufacturer: Keeler Instruments Inc.
Device Classification Name: tonometer, ac-powered
Regulation Number: 886.1930
Classification Product Code: HKX
Date Received: 05/01/2018
Decision Date: 02/08/2019
Regulation Medical Specialty: Ophthalmic
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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