| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
040
|
Date of Entry 08/14/2015
|
|
FR Recognition Number
|
10-96
|
| Standard | |
ANSI Z80.10-2014
American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers |
|
Scope/Abstract| This standard, together with ISO 15004-1:2009, Fundamental requirements and test methods - Part 1: General requirements applicable to all instruments - First edition, specifies minimum requirements and the design compliance procedure for tonometers intended for routine clinical use in the estimation of intraocular pressure (IOP) for the detection, diagnosis, and management of ocular abnormalities. |
|
Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Within Annex B:
-B.5.3 (Last paragraph)
-B.5.5
-B.7.2 |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §886.1930 |
Tonometer, Ac-Powered
|
Class 2
|
HKX
|
| §886.1930 |
Tonometer, Manual
|
Class 2
|
HKY
|
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Tonometers - Premarket Notification [510(k)] Submissions, Issued March 27, 2006.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
| FDA Technical Contact
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
