REPRO-MED SYSTEMS INFUSION DEVICE
FDA 510(k) clearance K844401 · decided 1985-03-12
Clearance details
- K-number
- K844401
- Device name
- REPRO-MED SYSTEMS INFUSION DEVICE
- Applicant
- Repro-Med Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-11-13
- Decision date
- 1985-03-12
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Middletown, NY, 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.
Recalls involving this device
No recalls on record reference this clearance.
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 |