Modified Radius - Model Number MM 5000
FDA 510(k) K871727 · Ultrasonix, Inc.
510(k) numberK871727
Submission
- Device name
- Modified Radius - Model Number MM 5000
- Applicant
- Ultrasonix, Inc.
N. Yonkers, NY, US - Received
- April 28, 1987
- Decision date
- September 30, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JOP – Transducer, Ultrasonic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2880
- Specialty
- Cardiovascular
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| K111416 | FalconJOP · Traditional | Viasonix , Ltd. | 07/15/2011SE |
| K071730 | Studiodop VicorderJOP · Abbreviated | Skidmore Medical, Limited | 12/20/2007SE |
| K010482 | Echoflow Portable Doppler Blood Flow Measurement System; Model PEF-1JOP · Special | Echocath, Inc. | 03/20/2001SE |
| K002766 | Nicolet VasoguardJOP · Abbreviated | Nicolet Biomedical | 11/30/2000SE |
| K990642 | Echoflow Doppler Blood Velocity MeterJOP · Traditional | Echocath, Inc. | 09/16/1999SE |
More from Echocath, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K851901 | 750 SD Ultrasound Scanner(Modification)DXK · Traditional | 10/23/1985SE |
Questions and answers
When was Modified Radius - Model Number MM 5000 cleared by the FDA?
Modified Radius - Model Number MM 5000 (K871727) received a 510(k) decision of Substantially Equivalent on September 30, 1987, 155 days after the submission was received.
What is the product code of K871727?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.