Dual Trace Video Monitor VM 410
FDA 510(k) K810165 · Honeywell, Inc.
510(k) numberK810165
Submission
- Device name
- Dual Trace Video Monitor VM 410
- Applicant
- Honeywell, Inc.
Mchenry, IL, US - Received
- January 22, 1981
- Decision date
- February 25, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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Questions and answers
When was Dual Trace Video Monitor VM 410 cleared by the FDA?
Dual Trace Video Monitor VM 410 (K810165) received a 510(k) decision of Substantially Equivalent on February 25, 1981, 34 days after the submission was received.
What is the product code of K810165?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.