DIGITILT LS-30 REMOTE CONTROL
FDA 510(k) clearance K834288 · decided 1983-12-29
Clearance details
- K-number
- K834288
- Device name
- DIGITILT LS-30 REMOTE CONTROL
- Applicant
- Elscint, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-11-28
- Decision date
- 1983-12-29
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- IZF
- Device class
- 2
- Regulation number
- 892.1740
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GYREX (P840007/S003) | Elscint, Inc. | 1988-04-26 |
| GYREX, MODELS S3500 & S5000 (P840007/S002) | Elscint, Inc. | 1987-10-08 |
| GYREX, MODELS S3500 & S5000 (P840007/S001) | Elscint, Inc. | 1987-04-02 |