Sgarlato Labs Painfree Pump and Pain Control Infusion Pump
FDA 510(k) K043204 · Sgarlato Laboratories, Inc.
510(k) numberK043204
Submission
- Device name
- Sgarlato Labs Painfree Pump and Pain Control Infusion Pump
- Applicant
- Sgarlato Laboratories, Inc.
Campbell, CA, US - Received
- November 18, 2004
- Decision date
- March 30, 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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More from Deka Research and Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K990101 | Pain Control Infusion PumpFRN · Traditional | 03/19/1999SE |
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| K926262 | First MPJ Continuous Passive Motion DeviceBXB · Traditional | 01/26/1994SE |
| K926237 | O'Brien GoniometerKQW · Traditional | 08/02/1993SE |
| K922292 | Lundeen Subtalar Peg ImplantMJW · Traditional | 10/23/1992SE |
| K905795 | Sgarlato Flexible Hinge Toe ImplantKWH · Traditional | 05/29/1991SE |
| K884739 | Sgarlato Lesser Toe ImplantKWH · Traditional | 05/18/1989SE |
Questions and answers
When was Sgarlato Labs Painfree Pump and Pain Control Infusion Pump cleared by the FDA?
Sgarlato Labs Painfree Pump and Pain Control Infusion Pump (K043204) received a 510(k) decision of Substantially Equivalent on March 30, 2005, 132 days after the submission was received.
What is the product code of K043204?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.