Mod 426, Medical Ultrasonic Diagnostc Transducer
FDA 510(k) K860235 · Hoffrel Instruments, Inc.
510(k) numberK860235
Submission
- Device name
- Mod 426, Medical Ultrasonic Diagnostc Transducer
- Applicant
- Hoffrel Instruments, Inc.
South Norwalk, CT, US - Received
- January 22, 1986
- Decision date
- May 15, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Vitrolife Sweden AB
| 510(k) | Device | Decision |
|---|---|---|
| K870850 | Mod 482JOP · Traditional | 09/08/1987SE |
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| 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 426, Medical Ultrasonic Diagnostc Transducer cleared by the FDA?
Mod 426, Medical Ultrasonic Diagnostc Transducer (K860235) received a 510(k) decision of Substantially Equivalent on May 15, 1986, 113 days after the submission was received.
What is the product code of K860235?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.