SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M.
FDA 510(k) clearance K965070 · decided 1997-03-06
Clearance details
- K-number
- K965070
- Device name
- SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M.
- Applicant
- Mecta Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-11
- Decision date
- 1997-03-06
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- QGH
- Device class
- 2
- Regulation number
- 882.5940
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Lake Oswego, OR, 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 |
|---|---|---|
| MECTA Sigma (K192834) | Mecta Corporation | 2020-04-26 |
| SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M (K960754) | Mecta Corp. | 1996-09-18 |
| THYMATRON 2000 ELECTROCONVULSIVE SYSTEM (K945120) | Somatics, Inc. | 1995-10-26 |
| MF-500, MODIFICATION (K911144) | Elcot, Inc. | 1991-10-18 |
| ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000 (K863815) | Elcot, Inc. | 1987-06-02 |
| ELECTROSHOCK UNIT NEUROLOGY MODEL B-25 (K860467) | Medcraft Corp. | 1986-11-10 |
| MECTA ECT DEVICE MODELS SR & JR (K852069) | Mecta Corp. | 1985-08-09 |
| THYMATRON (K843923) | Somatics, Inc. | 1984-12-03 |
Recalls involving this device
No recalls on record reference this clearance.