Smiths Medical Insulin Infusion Pump with Cozmonitor Glucose Meter
FDA 510(k) K031738 · Smiths Medical MD, Inc.
510(k) numberK031738
Submission
- Device name
- Smiths Medical Insulin Infusion Pump with Cozmonitor Glucose Meter
- Applicant
- Smiths Medical MD, Inc.
St. Paul, MN, US - Received
- June 4, 2003
- Decision date
- May 27, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZG – Pump, Infusion, Insulin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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Questions and answers
When was Smiths Medical Insulin Infusion Pump with Cozmonitor Glucose Meter cleared by the FDA?
Smiths Medical Insulin Infusion Pump with Cozmonitor Glucose Meter (K031738) received a 510(k) decision of Substantially Equivalent on May 27, 2004, 358 days after the submission was received.
What is the product code of K031738?
The FDA product code is LZG – Pump, Infusion, Insulin, a Class II (moderate risk) device regulated under 21 CFR 880.5725.