Diagnostic Ultrasound 105 & 110
FDA 510(k) K842539 · Diagnostic Ultrasound Corp.
510(k) numberK842539
Submission
- Device name
- Diagnostic Ultrasound 105 & 110
- Applicant
- Diagnostic Ultrasound Corp.
Kirkland, WA, US - Received
- June 28, 1984
- Decision date
- April 10, 1985
- 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 |
|---|---|---|
| K030763 | Diagnostic Ultrasound Bladdermass BVM 6500 Ultrasound SystemIYO · Traditional | 03/26/2003SE |
| K022153 | Bladderscan Bvi 6100IYO · Traditional | 08/15/2002SE |
| K982568 | Bladdermanager Pci 5000 Model 1002ITX · Traditional | 01/25/1999SE |
| K963585 | Bladder Manager Pci 5000, Bladderscan Bvi 5000IYO · Traditional | 10/01/1996SE |
| K955840 | Bladdermanager Pci 5000 / Bladderscan Bvi 5000IYO · Traditional | 05/24/1996SE |
| K955942 | Bladderscan Bvi 5000IYO · Traditional | 03/15/1996SE |
| K920664 | Diagnostic Ultrasound/Uro-Gyn Ups 2020, Gi VersionFFX · Traditional | 12/23/1993SE |
| K915342 | Ud 2000 Video OptionLLZ · Traditional | 06/10/1992SE |
| K915436 | Bladderscan Bvi 2500IYO · Traditional | 03/03/1992SE |
| K911166 | Diagnostic Ultrasound/Uro-Gyn Ud 511DXT · Traditional | 08/15/1991SE |
Questions and answers
When was Diagnostic Ultrasound 105 & 110 cleared by the FDA?
Diagnostic Ultrasound 105 & 110 (K842539) received a 510(k) decision of Substantially Equivalent on April 10, 1985, 286 days after the submission was received.
What is the product code of K842539?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.