CATS®-D Tonometer Prism

Tonometer, Manual

CATS Tonometer LLC

The following data is part of a premarket notification filed by Cats Tonometer Llc with the FDA for Cats®-d Tonometer Prism.

Pre-market Notification Details

• Device ID: K203850
• 510k Number: K203850
• Device Name: CATS®-D Tonometer Prism
• Classification: Tonometer, Manual
• Applicant: CATS Tonometer LLC 1517 N. Wilmot Suite 143 Tucson, AZ 85712
• Contact: Nannon Roosa
• Correspondent: Paul Kramsky; CATS Tonometer LLC 1517 N. Wilmot Suite 143 Tucson, AZ 85712
• Product Code: HKY
• CFR Regulation Number: 886.1930 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-12-31
• Decision Date: 2021-06-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860412001558	K203850	000