Zimmer Ambulatory Pump Pain Management System with Patient Control Module
FDA 510(k) K052171 · Zimmer, Inc.
510(k) numberK052171
Submission
- Device name
- Zimmer Ambulatory Pump Pain Management System with Patient Control Module
- Applicant
- Zimmer, Inc.
Dover, OH, US - Received
- August 9, 2005
- Decision date
- October 13, 2005
- 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 Zimmer Ambulatory Pump Pain Management System with Patient Control Module cleared by the FDA?
Zimmer Ambulatory Pump Pain Management System with Patient Control Module (K052171) received a 510(k) decision of Substantially Equivalent on October 13, 2005, 65 days after the submission was received.
What is the product code of K052171?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.