PERSYST PRISM
FDA 510(k) clearance K974718 · decided 1998-03-09
Clearance details
- K-number
- K974718
- Device name
- PERSYST PRISM
- Applicant
- Persyst Development Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-17
- Decision date
- 1998-03-09
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- GWS
- Device class
- 1
- Regulation number
- 882.1420
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Prescott, AZ, US
- Third-party review
- No
- Expedited review
- No
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| CNS 4/8 AND CT 48.1 SOFTWARE (K860829) | Cns, Inc. | 1986-05-29 |
| CNS-16 & LTM 1.0 SOFTWARE (K854160) | Cns, Inc. | 1986-01-10 |
| NEUROSCIENCE MAP-10 EEG (K850430) | Neuroscience, Inc. | 1985-07-17 |
| NEUROLAB II (K844481) | Teca, Inc. | 1985-05-20 |
| CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE (K844015) | Cns, Inc. | 1984-12-17 |
| MEUROMETRICS MONITOR (K803233) | Dade Medical, Inc. | 1981-01-12 |
Recalls involving this device
No recalls on record reference this clearance.