Optical Topography System ETG-4100
FDA 510(k) K172492 · Hitachi Healthcare Americas
510(k) numberK172492
Submission
- Device name
- Optical Topography System ETG-4100
- Applicant
- Hitachi Healthcare Americas
Twinsburg, OH, US - Received
- August 17, 2017
- Decision date
- August 17, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQA – Oximeter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Specialty
- Cardiovascular
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Questions and answers
When was Optical Topography System ETG-4100 cleared by the FDA?
Optical Topography System ETG-4100 (K172492) received a 510(k) decision of Substantially Equivalent on August 17, 2018, 365 days after the submission was received.
What is the product code of K172492?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.