510(k) K921863
- Device
- SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS
- Applicant
- HEWLETT-PACKARD CO.
- 510(k) number
- K921863
- Product code
- GXW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-09-28
- Date received
- 1992-04-17
- Regulation
- 882.1240
- Classification name
- Echoencephalograph
- Medical specialty
- Neurology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHARLES R BURR
- Address
- 3000 Minuteman Rd. Andover MA US 01810 01810
Source Documents#
Other 510(k) Records For Product Code GXW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K833522 | NEURO SECTOR FIXATION DEVICE | Advanced Technology Laboratories, Inc. | 1984-05-25 |
| 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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