Echocardiography Sys., Model 3860
FDA 510(k) K770756 · Honeywell, Inc.
510(k) numberK770756
Submission
- Device name
- Echocardiography Sys., Model 3860
- Applicant
- Honeywell, Inc.
Mchenry, IL, US - Received
- April 25, 1977
- Decision date
- May 9, 1977
- 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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| K850794 | Patient Monitor Model RM-300DTR · Traditional | 04/18/1985SE |
| K851092 | Portable Defibrillator/Monitor Ed 425LDD · Traditional | 04/10/1985SE |
| K834530 | Extension Box EB200DRT · Traditional | 06/01/1984SE |
| K834282 | Ultra Imager 2000IYO · Traditional | 04/23/1984SE |
Questions and answers
When was Echocardiography Sys., Model 3860 cleared by the FDA?
Echocardiography Sys., Model 3860 (K770756) received a 510(k) decision of Substantially Equivalent on May 9, 1977, 14 days after the submission was received.
What is the product code of K770756?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.