FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING
FDA 510(k) clearance K933652 · decided 1994-05-18
Clearance details
- K-number
- K933652
- Device name
- FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING
- Applicant
- Repro-Med Systems, Inc.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1993-07-28
- Decision date
- 1994-05-18
- Days to decision
- 294 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- West Cadwell, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F recall (Z-0317-2018) | Repro-Med Systems, Inc. | 2018-01-05 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| REPRO-MED - THD (P820034/S005) | Repro-Med Systems, Inc. | 1997-01-14 |
| REPRO-MED - THD (P820034/S004) | Repro-Med Systems, Inc. | 1993-04-29 |
| REPRO-MED - THD ADDRESS CHANGE / MANU. FACILITY (P820034/S003) | Repro-Med Systems, Inc. | 1993-04-28 |
| REPRO-MED - THD (P820034/S002) | Repro-Med Systems, Inc. | 1987-05-12 |
| REPRO-MED - THD (P820034/S001) | Repro-Med Systems, Inc. | 1985-01-31 |
| REPRO-MED - THD (P820034) | Repro-Med Systems, Inc. | 1984-12-26 |