Paradigm 1.5ML Reservoir, Model 326
FDA 510(k) K001828 · Minimed, Inc.
510(k) numberK001828
Submission
- Device name
- Paradigm 1.5ML Reservoir, Model 326
- Applicant
- Minimed, Inc.
Sylmar, CA, US - Received
- June 16, 2000
- Decision date
- August 18, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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.
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|---|---|---|
| K031541 | Paradigmpal, Model MMT-7330LZG · Traditional | 11/18/2003SE |
| K031390 | Medtronic Minimed Paradigm Insulin Pump, Model MMT-712LGZ · Traditional | 07/23/2003SE |
| K030531 | Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link Glucose MeterLZG · Traditional | 06/17/2003SE |
| K021974 | Medtronic Minimed Comlink, Hardware Model 7304 & Software Model 7311MRZ · Traditional | 08/06/2002SE |
| K010377 | Mimimed Sil-Serter Infusion Set Insertion System, Model 385KZH · Traditional | 04/05/2001SE |
| K001832 | Paradigm Sof-Set Ultimate QR, Models 317 and 318FPA · Traditional | 08/18/2000SE |
| K001829 | Minimed Paradigm Insulin Pump, Model 511FRN · Traditional | 08/18/2000SE |
| K001827 | Paradigm Sof-Set Micro QR, Models 324 and 325FPA · Traditional | 08/18/2000SE |
Questions and answers
When was Paradigm 1.5ML Reservoir, Model 326 cleared by the FDA?
Paradigm 1.5ML Reservoir, Model 326 (K001828) received a 510(k) decision of Substantially Equivalent on August 18, 2000, 63 days after the submission was received.
What is the product code of K001828?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.