RHYTHM
FDA 510(k) clearance K912938 · decided 1991-07-30
Clearance details
- K-number
- K912938
- Device name
- RHYTHM
- Applicant
- Stellate Systems
- Decision
- Substantially Equivalent
- Date received
- 1991-07-05
- Decision date
- 1991-07-30
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- GWS
- Device class
- 1
- Regulation number
- 882.1420
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Westmount, Quebec, CA
- 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 |
|---|---|---|
| PERSYST PRISM (K974718) | Persyst Development Corp. | 1998-03-09 |
| EEG ANALYZER (K925735) | Bio-Scan, Inc. | 1993-12-03 |
| NICOLET BEAM II SYSTEM (K894629) | Nicolet Instrument Corp. | 1990-03-09 |
| ISTAT SOFTWARE (K871931) | Neuroscience, Inc. | 1987-10-13 |
| STD-228 SPECTRAL TREND DISPLAY (K871480) | Grass-Telefactor Product Group | 1987-05-01 |
| OEE_7102 EEG/TREND MONITOR (K854662) | Nihon Kohden America, Inc. | 1986-08-20 |
| 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.