Avi Infusion Pumps, Additional Intended Use
FDA 510(k) K933006 · 3M Health Care, Ltd.
510(k) numberK933006
Submission
- Device name
- Avi Infusion Pumps, Additional Intended Use
- Applicant
- 3M Health Care, Ltd.
St. Paul, MN, US - Received
- June 21, 1993
- Decision date
- October 25, 1993
- 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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Questions and answers
When was Avi Infusion Pumps, Additional Intended Use cleared by the FDA?
Avi Infusion Pumps, Additional Intended Use (K933006) received a 510(k) decision of Substantially Equivalent on October 25, 1993, 126 days after the submission was received.
What is the product code of K933006?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.