GXWClass II
Echoencephalograph
21 CFR 882.1240 / Neurology
GXW is the FDA product code for Echoencephalograph, a class II device type, regulated under 21 CFR 882.1240. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- GXW
- Device name
- Echoencephalograph
- Regulation
- 21 CFR 882.1240
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 7
- Ingested recalls
- 0
Clearances, product code GXW
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1982 | 1 |
| 1984 | 1 |
| 1986 | 1 |
| 1990 | 1 |
| 1992 | 1 |
Applicants with the most clearances
Product code GXW| Applicant | Clearances |
|---|---|
| Storz Instrument Co. | 2 |
| Advanced Technology Laboratories, Inc. | 1 |
| Diasonics, Inc. | 1 |
| Hewlett-Packard Co. | 1 |
| Rabar, Inc. | 1 |
| Toshiba America Medical Systems, In.C | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code GXW.
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