QWIK-1(TM) In-Line IV Fluid Warmer
FDA 510(k) K914867 · Microwave Medical Systems, Inc.
510(k) numberK914867
Submission
- Device name
- QWIK-1(TM) In-Line IV Fluid Warmer
- Applicant
- Microwave Medical Systems, Inc.
Littleton, MA, US - Received
- October 29, 1991
- Decision date
- October 23, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LGZ – Warmer, Thermal, Infusion Fluid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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Questions and answers
When was QWIK-1(TM) In-Line IV Fluid Warmer cleared by the FDA?
QWIK-1(TM) In-Line IV Fluid Warmer (K914867) received a 510(k) decision of Substantially Equivalent on October 23, 1992, 360 days after the submission was received.
What is the product code of K914867?
The FDA product code is LGZ – Warmer, Thermal, Infusion Fluid, a Class II (moderate risk) device regulated under 21 CFR 880.5725.