Nidek Model NT-1000
FDA 510(k) K913189 · Nidek, Inc.
510(k) numberK913189
Submission
- Device name
- Nidek Model NT-1000
- Applicant
- Nidek, Inc.
Palo Alto, CA, US - Received
- July 18, 1991
- Decision date
- October 15, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HKX – Tonometer, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1930
- Specialty
- Ophthalmic
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Questions and answers
When was Nidek Model NT-1000 cleared by the FDA?
Nidek Model NT-1000 (K913189) received a 510(k) decision of Substantially Equivalent on October 15, 1991, 89 days after the submission was received.
What is the product code of K913189?
The FDA product code is HKX – Tonometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1930.