Cathode Ray Tube Display Model 1340A
FDA 510(k) K780332 · Hewlett-Packard Co.
510(k) numberK780332
Submission
- Device name
- Cathode Ray Tube Display Model 1340A
- Applicant
- Hewlett-Packard Co.
Mchenry, IL, US - Received
- February 28, 1978
- Decision date
- March 22, 1978
- 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 Cathode Ray Tube Display Model 1340A cleared by the FDA?
Cathode Ray Tube Display Model 1340A (K780332) received a 510(k) decision of Substantially Equivalent on March 22, 1978, 22 days after the submission was received.
What is the product code of K780332?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.