View Archiving Station
FDA 510(k) K971176 · Electromed Intl., Ltd.
510(k) numberK971176
Submission
- Device name
- View Archiving Station
- Applicant
- Electromed Intl., Ltd.
Quebec, CA - Received
- March 31, 1997
- Decision date
- September 3, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was View Archiving Station cleared by the FDA?
View Archiving Station (K971176) received a 510(k) decision of Substantially Equivalent on September 3, 1997, 156 days after the submission was received.
What is the product code of K971176?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.