GXW — Echoencephalograph Class II
FDA product code GXW covers "Echoencephalograph", a Class II medical device regulated under 21 CFR 882.1240. Submissions are reviewed by the Neurology panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GXW
- Device Class
- Class II
- Regulation Number
- 882.1240
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K921863 | hewlett-packard | SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS | September 28, 1992 |
| K903085 | toshiba america medical systems, in.c | SMS-712NA | October 5, 1990 |
| K853432 | diasonics | 5.0 IOP & 7.5 IOP PROBES | February 7, 1986 |
| K833522 | advanced technology laboratories | NEURO SECTOR FIXATION DEVICE | May 25, 1984 |
| K821736 | rabar | ECHO-PULSE KM555 | December 9, 1982 |
| K770788 | storz instrument | ECHOENCEPHALOGRAPH, DIGITAL,DIGIECHO2000 | May 6, 1977 |
| K770575 | storz instrument | ECHOENCEPHALOGRAPH, DIGITAL, 1000 | April 26, 1977 |