Nikkiso Infusion Pump Model PFA-02
FDA 510(k) K861539 · International Medical Products, Inc.
510(k) numberK861539
Submission
- Device name
- Nikkiso Infusion Pump Model PFA-02
- Applicant
- International Medical Products, Inc.
Minneapolis, MN, US - Received
- April 24, 1986
- Decision date
- July 31, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K900755 | Digital Cuff PV GaugeBSK · Traditional | 04/26/1990SE |
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Questions and answers
When was Nikkiso Infusion Pump Model PFA-02 cleared by the FDA?
Nikkiso Infusion Pump Model PFA-02 (K861539) received a 510(k) decision of Substantially Equivalent on July 31, 1986, 98 days after the submission was received.
What is the product code of K861539?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.