Ambit Intermittent Ambulatory Infusion Pump
FDA 510(k) K033425 · Sorenson Medical, Inc.
510(k) numberK033425
Submission
- Device name
- Ambit Intermittent Ambulatory Infusion Pump
- Applicant
- Sorenson Medical, Inc.
West Jordan, UT, US - Received
- October 27, 2003
- Decision date
- November 6, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K052221 | Ambit Push & Play Ambulatory Infusion PumpFRN · Abbreviated | 12/08/2005SE |
| K033325 | Ambit Continuous Ambulatory Infusion PumpFRN · Special | 11/06/2003SE |
| K002434 | Palm PumpMEA · Special | 08/23/2000SE |
| K001287 | Empty Reservoir Bag, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 MLKPE · Traditional | 06/09/2000SE |
| K991363 | 30 Pump, Continuous Low Flow, 200 Pump, Intermittent with Kvo or Continuous, Pca Pump…FRN · Special | 05/13/1999SE |
Questions and answers
When was Ambit Intermittent Ambulatory Infusion Pump cleared by the FDA?
Ambit Intermittent Ambulatory Infusion Pump (K033425) received a 510(k) decision of Substantially Equivalent on November 6, 2003, 10 days after the submission was received.
What is the product code of K033425?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.