SOMAS HUMAN SPINAL FLUID CONTROL
FDA 510(k) clearance K840974 · decided 1984-04-05
Clearance details
- K-number
- K840974
- Device name
- SOMAS HUMAN SPINAL FLUID CONTROL
- Applicant
- Somas Medical Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-03-06
- Decision date
- 1984-04-05
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- DFI
- Device class
- 1
- Regulation number
- 866.5860
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- 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 |
|---|---|---|
| CANTROL SPINAL FLUID CONTROL (K854190) | Canyon Diagnostics, Inc. | 1985-11-25 |
| RESOLVE-CSF (K843122) | Isolab, Inc. | 1984-11-30 |
| FIAX IGG TEST (K832821) | Intl. Diagnostic Technology | 1983-10-14 |
Recalls involving this device
No recalls on record reference this clearance.