EVOKED RESPONSE SYS., MODEL 10
FDA 510(k) clearance K771742 · decided 1977-11-22
Clearance details
- K-number
- K771742
- Device name
- EVOKED RESPONSE SYS., MODEL 10
- Applicant
- Grass Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1977-09-15
- Decision date
- 1977-11-22
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- GWK
- Device class
- 2
- Regulation number
- 882.1845
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| ASC-954 INTEGRATOR AMPLIFIER (K896164) | Astro-Med, Inc. | 1990-01-22 |
| NICOLET BRAINLAB SYSTEM (K882599) | Nicolet Instrument Corp. | 1988-10-19 |
| BIO-LOGIC BANKER (K872290) | Bio-Logic Systems Corp. | 1987-10-06 |
| DD-VCR-64 (K870381) | Grass-Telefactor Product Group | 1987-03-25 |
| ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV (K860914) | Bio-Feedback Systems, Inc. | 1986-06-06 |
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Recalls involving this device
No recalls on record reference this clearance.