Irregular Curve Tracing Revisition & Doppler
FDA 510(k) K853769 · Hewlett-Packard Co.
510(k) numberK853769
Submission
- Device name
- Irregular Curve Tracing Revisition & Doppler
- Applicant
- Hewlett-Packard Co.
Andover, MA, US - Received
- September 9, 1985
- Decision date
- October 31, 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 Irregular Curve Tracing Revisition & Doppler cleared by the FDA?
Irregular Curve Tracing Revisition & Doppler (K853769) received a 510(k) decision of Substantially Equivalent on October 31, 1985, 52 days after the submission was received.
What is the product code of K853769?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.