Kodak Ektasian HG Film (EHG-15)
FDA 510(k) K970154 · Eastman Kodak Company
510(k) numberK970154
Submission
- Device name
- Kodak Ektasian HG Film (EHG-15)
- Applicant
- Eastman Kodak Company
Rochester, NY, US - Received
- January 16, 1997
- Decision date
- April 4, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Kodak Ektasian HG Film (EHG-15) cleared by the FDA?
Kodak Ektasian HG Film (EHG-15) (K970154) received a 510(k) decision of Substantially Equivalent on April 4, 1997, 78 days after the submission was received.
What is the product code of K970154?
The FDA product code is IWZ – Film, Radiographic, a Class I (low risk) device regulated under 21 CFR 892.1840.