Smartdose IV Prefilled Infusion Container
FDA 510(k) K944351 · River Medical, Inc.
510(k) numberK944351
Submission
- Device name
- Smartdose IV Prefilled Infusion Container
- Applicant
- River Medical, Inc.
San Diego, CA, US - Received
- September 6, 1994
- Decision date
- November 15, 1995
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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More from Deka Research and Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K023174 | Disposable Temporary Pacing WireLDF · Traditional | 06/11/2003SE |
| K944352 | Smartdose III Infusion ContainerFRN · Traditional | 11/15/1995ST |
| K945298 | Smartflow I Administration SetFPA · Traditional | 06/14/1995SE |
| K943692 | Smart Dose(Tm)FRN · Traditional | 04/28/1995ST |
| K932895 | River PumpFRN · Traditional | 03/31/1994SE |
| K933335 | River Vial AdapterFMF · Traditional | 03/01/1994SE |
| K915120 | Tef/Platinum PistonETB · Traditional | 12/27/1991SE |
| K915121 | Tef/Wire PistonETB · Traditional | 12/23/1991SE |
| K913287 | H/A Partial - Regular & H/A Partial - OffsetETB · Traditional | 12/18/1991SE |
| K913286 | H/A Total-Regular, H/A Total-OffsetETA · Traditional | 12/18/1991SE |
Questions and answers
When was Smartdose IV Prefilled Infusion Container cleared by the FDA?
Smartdose IV Prefilled Infusion Container (K944351) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on November 15, 1995, 435 days after the submission was received.
What is the product code of K944351?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.