5.0 IOP & 7.5 IOP PROBES
FDA 510(k) clearance K853432 · decided 1986-02-07
Clearance details
- K-number
- K853432
- Device name
- 5.0 IOP & 7.5 IOP PROBES
- Applicant
- Diasonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-08-15
- Decision date
- 1986-02-07
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- GXW
- Device class
- 2
- Regulation number
- 882.1240
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Milipitas, CA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| 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 |
| NEURO SECTOR FIXATION DEVICE (K833522) | Advanced Technology Laboratories, Inc. | 1984-05-25 |
| ECHO-PULSE KM555 (K821736) | Rabar, Inc. | 1982-12-09 |
| ECHOENCEPHALOGRAPH, DIGITAL,DIGIECHO2000 (K770788) | Storz Instrument Co. | 1977-05-06 |
| ECHOENCEPHALOGRAPH, DIGITAL, 1000 (K770575) | Storz Instrument Co. | 1977-04-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| DIASONICS NMR IMAGING SYSTEM (P830053/S030) | Diasonics, Inc. | 1988-07-27 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S029) | Diasonics, Inc. | 1988-07-07 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S028) | Diasonics, Inc. | 1988-03-03 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S026) | Diasonics, Inc. | 1987-07-13 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S027) | Diasonics, Inc. | 1987-06-22 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S022) | Diasonics, Inc. | 1987-03-30 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S025) | Diasonics, Inc. | 1987-03-20 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S024) | Diasonics, Inc. | 1987-03-17 |