ECHOENCEPHALOGRAPH, DIGITAL,DIGIECHO2000
FDA 510(k) clearance K770788 · decided 1977-05-06
Clearance details
- K-number
- K770788
- Device name
- ECHOENCEPHALOGRAPH, DIGITAL,DIGIECHO2000
- Applicant
- Storz Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1977-05-02
- Decision date
- 1977-05-06
- Days to decision
- 4 days
- Clearance type
- Traditional
- Product code
- GXW
- Device class
- 2
- Regulation number
- 882.1240
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS (K921863) | Hewlett-Packard Co. | 1992-09-28 |
| SMS-712NA (K903085) | Toshiba America Medical Systems, In.C | 1990-10-05 |
| 5.0 IOP & 7.5 IOP PROBES (K853432) | Diasonics, Inc. | 1986-02-07 |
| NEURO SECTOR FIXATION DEVICE (K833522) | Advanced Technology Laboratories, Inc. | 1984-05-25 |
| ECHO-PULSE KM555 (K821736) | Rabar, Inc. | 1982-12-09 |
| ECHOENCEPHALOGRAPH, DIGITAL, 1000 (K770575) | Storz Instrument Co. | 1977-04-26 |
Recalls involving this device
No recalls on record reference this clearance.