ARMEX LS-51
FDA 510(k) clearance K837175 · decided 1983-03-17
Clearance details
- K-number
- K837175
- Device name
- ARMEX LS-51
- Applicant
- Elscint, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-02-16
- Decision date
- 1983-03-17
- Days to decision
- 29 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Hackensack, NJ, 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 |