Mod 427
FDA 510(k) K834277 · Hoffrel Instruments, Inc.
510(k) numberK834277
Submission
- Device name
- Mod 427
- Applicant
- Hoffrel Instruments, Inc.
Mchenry, IL, US - Received
- October 31, 1983
- Decision date
- February 17, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Accutome, Inc. Doing Business AS Keeler USA
| 510(k) | Device | Decision |
|---|---|---|
| K870850 | Mod 482JOP · Traditional | 09/08/1987SE |
| K860235 | Mod 426, Medical Ultrasonic Diagnostc TransducerITX · Traditional | 05/15/1986SE |
| K850165 | Motor Drive, Mechanical Sector SCANNING-MOD417JOP · Traditional | 10/23/1985SE |
| K844916 | Model 518 & 519 Ultrasonoscope W/DopplerIYO · Traditional | 04/22/1985SE |
| 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 Mod 427 cleared by the FDA?
Mod 427 (K834277) received a 510(k) decision of Substantially Equivalent on February 17, 1984, 109 days after the submission was received.
What is the product code of K834277?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.