Bodygaurd Pain Manager Infusion System
FDA 510(k) K061325 · Caesarea Medical Electronics , Ltd.
510(k) numberK061325
Submission
- Device name
- Bodygaurd Pain Manager Infusion System
- Applicant
- Caesarea Medical Electronics , Ltd.
Caesarea, IL - Received
- May 11, 2006
- Decision date
- August 24, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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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More from Deka Research and Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K080954 | T34L Syringe DriverFRN · Special | 05/16/2008SE |
| K070235 | Bodyguard Pain Manager Infusion SystemFRN · Special | 05/18/2007SE |
| K070718 | Modification to: Bodyguard Infusion SystemFRN · Special | 04/13/2007SE |
| K060479 | Modification to Bodyguard Infusion Pump SystemFRN · Traditional | 05/12/2006SE |
| K050800 | Niki T34 and Bodyguard T34 Syringe DriversFRN · Traditional | 11/23/2005SE |
| K042696 | Bodyguard Infusion Pump SystemFRN · Traditional | 03/11/2005SE |
| K040957 | Noa III Enteral Nutrition PumpLZH · Traditional | 05/21/2004SE |
| K031749 | Bodyguard Infusion SystemFRN · Traditional | 08/21/2003SE |
Questions and answers
When was Bodygaurd Pain Manager Infusion System cleared by the FDA?
Bodygaurd Pain Manager Infusion System (K061325) received a 510(k) decision of Substantially Equivalent on August 24, 2006, 105 days after the submission was received.
What is the product code of K061325?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.