Transesophageal Echocardiography Ultraso
FDA 510(k) K843262 · Hewlett-Packard Co.
510(k) numberK843262
Submission
- Device name
- Transesophageal Echocardiography Ultraso
- Applicant
- Hewlett-Packard Co.
Walker, MI, US - Received
- August 20, 1984
- Decision date
- August 23, 1984
- 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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| K242662 | Falcon/Xpress (Falcon/Xpress)JOP · Traditional | Viasonix , Ltd. | 12/18/2024SE |
| K233976 | VasoGuard (V10, V8, V6, V4, V2)JOP · Traditional | Corvascular Diagnostics, LLC | 07/19/2024SE |
| K153762 | Smartdop XT6JOP · Traditional | Koven Technology, Inc. | 05/25/2016SE |
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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 |
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| K993587 | HP M2376A Device Link SystemMQS · Traditional | 01/20/2000SE |
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| K992674 | HP Viridia CMS Patient Monitor with EEG Parameter, Model M1027AMHX · Abbreviated | 11/08/1999SE |
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Questions and answers
When was Transesophageal Echocardiography Ultraso cleared by the FDA?
Transesophageal Echocardiography Ultraso (K843262) received a 510(k) decision of Substantially Equivalent on August 23, 1984, 3 days after the submission was received.
What is the product code of K843262?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.