Power Infuser, Model M100B-3A
FDA 510(k) K090736 · ZOLL Medical Corporation
510(k) numberK090736
Submission
- Device name
- Power Infuser, Model M100B-3A
- Applicant
- ZOLL Medical Corporation
Chelmsford, MA, US - Received
- March 19, 2009
- Decision date
- May 20, 2009
- 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 Power Infuser, Model M100B-3A cleared by the FDA?
Power Infuser, Model M100B-3A (K090736) received a 510(k) decision of Substantially Equivalent on May 20, 2009, 62 days after the submission was received.
What is the product code of K090736?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.