Model MD-5 Doppler
FDA 510(k) K901592 · D. E. Hokanson, Inc.
510(k) numberK901592
Submission
- Device name
- Model MD-5 Doppler
- Applicant
- D. E. Hokanson, Inc.
Bellevue, WA, US - Received
- April 5, 1990
- Decision date
- October 22, 1990
- 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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| K973426 | Ans 2000 ECG Monitor and Respiration PacerDPS · Traditional | 08/12/1998SE |
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| K932852 | Non Invasive Vascular ProgramJOB · Traditional | 02/04/1994SE |
| K932812 | Ec 5R PlethysmographJEH · Traditional | 01/13/1994SE |
| K932851 | Disposable Penile Blood Pressure CuffsDXQ · Traditional | 11/15/1993SE |
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Questions and answers
When was Model MD-5 Doppler cleared by the FDA?
Model MD-5 Doppler (K901592) received a 510(k) decision of Substantially Equivalent on October 22, 1990, 200 days after the submission was received.
What is the product code of K901592?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.