TRENDO-SCOPE
FDA 510(k) clearance K831995 · decided 1983-08-08
Clearance details
- K-number
- K831995
- Device name
- TRENDO-SCOPE
- Applicant
- Gabriel Ent.
- Decision
- Substantially Equivalent
- Date received
- 1983-06-21
- Decision date
- 1983-08-08
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- HCS
- Device class
- 2
- Regulation number
- 882.1570
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| POS T-7000 (K981805) | Pos Technologies, Inc. | 1998-08-07 |
| TYTRON C-3000 (K974208) | Titronics Research & Development Co. | 1998-02-03 |
| NEUROREADER (K950986) | Artronics | 1995-11-09 |
| THERMALGRAPHIC ANALYSER (K894772) | Medtech Instruments | 1989-10-03 |
| T-METER (K840487) | K.J. Electronics | 1984-03-12 |
| GABRIEL DIGITREND (K822795) | Gabriel Ent. | 1982-10-08 |
| EXOPHTHALMOMETER (K821107) | Medical Equipment Designs, Inc. | 1982-06-14 |
Recalls involving this device
No recalls on record reference this clearance.