Del Mar Avionics 8300 Sector Imager Sys
FDA 510(k) K844896 · Del Mar Avionics
510(k) numberK844896
Submission
- Device name
- Del Mar Avionics 8300 Sector Imager Sys
- Applicant
- Del Mar Avionics
Irvine, CA, US - Received
- December 17, 1984
- Decision date
- June 10, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXK – Echocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2330
- Specialty
- Cardiovascular
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Questions and answers
When was Del Mar Avionics 8300 Sector Imager Sys cleared by the FDA?
Del Mar Avionics 8300 Sector Imager Sys (K844896) received a 510(k) decision of Substantially Equivalent on June 10, 1985, 175 days after the submission was received.
What is the product code of K844896?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.