510(k) K833522
- Device
- NEURO SECTOR FIXATION DEVICE
- Applicant
- ADVANCED TECHNOLOGY LABORATORIES, INC.
- 510(k) number
- K833522
- Product code
- GXW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-05-25
- Date received
- 1983-09-19
- Regulation
- 882.1240
- Classification name
- Echoencephalograph
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GXW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K921863 | SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS | Hewlett-Packard Co. | 1992-09-28 |
| K903085 | SMS-712NA | Toshiba America Medical Systems, In.C | 1990-10-05 |
| K853432 | 5.0 IOP & 7.5 IOP PROBES | Diasonics, Inc. | 1986-02-07 |
| K821736 | ECHO-PULSE KM555 | Rabar, Inc. | 1982-12-09 |
| K770788 | ECHOENCEPHALOGRAPH, DIGITAL,DIGIECHO2000 | Storz Instrument Co. | 1977-05-06 |
| K770575 | ECHOENCEPHALOGRAPH, DIGITAL, 1000 | Storz Instrument Co. | 1977-04-26 |
Legacy Summary#
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FDA Review#
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