The Galileo Line -- Planet 100, 200 & 300 & Star
FDA 510(k) K923860 · Biosound, Inc.
510(k) numberK923860
Submission
- Device name
- The Galileo Line -- Planet 100, 200 & 300 & Star
- Applicant
- Biosound, Inc.
Indianapolis, IN, US - Received
- July 31, 1992
- Decision date
- February 4, 1993
- 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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| K953819 | Diagnostic Ultrasound TranducerITX · Traditional | 03/01/1996SE |
| K953759 | Diagnostic Ultrasound TransducerITX · Traditional | 03/01/1996SE |
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Questions and answers
When was The Galileo Line -- Planet 100, 200 & 300 & Star cleared by the FDA?
The Galileo Line -- Planet 100, 200 & 300 & Star (K923860) received a 510(k) decision of Substantially Equivalent on February 4, 1993, 188 days after the submission was received.
What is the product code of K923860?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.