Accupen
FDA 510(k) K083377 · Accutome Ultrasound, Inc.
510(k) numberK083377
Submission
- Device name
- Accupen
- Applicant
- Accutome Ultrasound, Inc.
Malvern, PA, US - Received
- November 14, 2008
- Decision date
- July 27, 2009
- 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 Accupen cleared by the FDA?
Accupen (K083377) received a 510(k) decision of Substantially Equivalent on July 27, 2009, 255 days after the submission was received.
What is the product code of K083377?
The FDA product code is HKX – Tonometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1930.