Motor Drive, Mechanical Sector SCANNING-MOD417
FDA 510(k) K850165 · Hoffrel Instruments, Inc.
510(k) numberK850165
Submission
- Device name
- Motor Drive, Mechanical Sector SCANNING-MOD417
- Applicant
- Hoffrel Instruments, Inc.
South Norwalk, CT, US - Received
- January 16, 1985
- Decision date
- October 23, 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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|---|---|---|---|
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| 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 |
| K131623 | Smartdop XTJOP · Traditional | Koven Technology, Inc. | 01/17/2014SE |
| K131860 | Vasculab VL4000 Photoplethysmograph with Pulse Volume RecordingJOP · Traditional | Us Vascular, LLC | 09/27/2013SE |
| 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 |
|---|---|---|
| K870850 | Mod 482JOP · Traditional | 09/08/1987SE |
| K860235 | Mod 426, Medical Ultrasonic Diagnostc TransducerITX · Traditional | 05/15/1986SE |
| K844916 | Model 518 & 519 Ultrasonoscope W/DopplerIYO · Traditional | 04/22/1985SE |
| K834277 | Mod 427IYO · Traditional | 02/17/1984SE |
| K834276 | Mod 456IYO · Traditional | 02/17/1984SE |
| K837282 | Model VPS Vascular Profile System · Traditional | 04/26/1983SE |
| K837229 | Transducer Models 450, 451, 452, 453, 454 · Traditional | 04/15/1983SE |
| K837142 | Transducers Models 421, 419 and 420 for Irex System · Traditional | 03/23/1983SE |
| K800364 | Ultrasonic Diagnostic System, Mod. 202DKX · Traditional | 03/12/1980SE |
| K790396 | Ultrasonic Diagnostic SystemIYO · Traditional | 03/21/1979SE |
Questions and answers
When was Motor Drive, Mechanical Sector SCANNING-MOD417 cleared by the FDA?
Motor Drive, Mechanical Sector SCANNING-MOD417 (K850165) received a 510(k) decision of Substantially Equivalent on October 23, 1985, 280 days after the submission was received.
What is the product code of K850165?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.