PAINPUMP1; PAINPUMP2
FDA 510(k) K042405 · Stryker Corp.
510(k) numberK042405
Submission
- Device name
- PAINPUMP1; PAINPUMP2
- Applicant
- Stryker Corp.
Kalamazoo, MI, US - Received
- September 3, 2004
- Decision date
- October 14, 2004
- 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 PAINPUMP1; PAINPUMP2 cleared by the FDA?
PAINPUMP1; PAINPUMP2 (K042405) received a 510(k) decision of Substantially Equivalent on October 14, 2004, 41 days after the submission was received.
What is the product code of K042405?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.