La Mont Video Patient Monitoring System
FDA 510(k) K921485 · Medical Systems Corp.
510(k) numberK921485
Submission
- Device name
- La Mont Video Patient Monitoring System
- Applicant
- Medical Systems Corp.
Nww 2070 Australia, AT - Received
- March 30, 1992
- Decision date
- October 22, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GWQ – Full-Montage Standard Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations
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Questions and answers
When was La Mont Video Patient Monitoring System cleared by the FDA?
La Mont Video Patient Monitoring System (K921485) received a 510(k) decision of Substantially Equivalent on October 22, 1992, 206 days after the submission was received.
What is the product code of K921485?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.