620CSR Display Driver
FDA 510(k) K932894 · Vidco, Inc.
510(k) numberK932894
Submission
- Device name
- 620CSR Display Driver
- Applicant
- Vidco, Inc.
Beaverton, OR, US - Received
- June 14, 1993
- Decision date
- June 20, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2450
- Specialty
- Cardiovascular
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| K926298 | 520 Display Driver- Status IDRT · Traditional | 05/04/1994SE |
| K926219 | 516YT Display DriverDXJ · Traditional | 12/16/1993SE |
| K926162 | 580CD Display DriverDXJ · Traditional | 11/08/1993SE |
| K890353 | SMDS460 Surgical Monitor Display SystemDXJ · Traditional | 03/02/1989SE |
Questions and answers
When was 620CSR Display Driver cleared by the FDA?
620CSR Display Driver (K932894) received a 510(k) decision of Substantially Equivalent on June 20, 1994, 371 days after the submission was received.
What is the product code of K932894?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.