Mod 456
FDA 510(k) K834276 · Hoffrel Instruments, Inc.
510(k) numberK834276
Submission
- Device name
- Mod 456
- 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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| 510(k) | Device | Decision |
|---|---|---|
| K870850 | Mod 482JOP · Traditional | 09/08/1987SE |
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Questions and answers
When was Mod 456 cleared by the FDA?
Mod 456 (K834276) 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 K834276?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.