Modified Labeling to Model 2000 Ambulatory Infuser
FDA 510(k) K863532 · Parker Hannifin Corp.
510(k) numberK863532
Submission
- Device name
- Modified Labeling to Model 2000 Ambulatory Infuser
- Applicant
- Parker Hannifin Corp.
Irvine, CA, US - Received
- September 9, 1986
- Decision date
- January 14, 1987
- 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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| K242115 | Plum Duo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
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| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) InjectionFRN · Special | Deka Research & Development Corp. | 03/11/2025SE |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRN · Traditional | Deka Research and Development Corp. | 01/16/2025SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K241465 | Midas Flowmeter; eAVSBZR · Traditional | 09/19/2024SE |
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| K202480 | Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50BZR · Traditional | 04/22/2021SE |
| K173530 | Indego(R)PHL · Traditional | 01/31/2018SE |
| K171334 | IndegoPHL · Traditional | 09/08/2017SE |
| K161731 | Cleveland Multiport Ventricular Catheter SetHCA · Traditional | 03/27/2017SE |
| K152416 | IndegoPHL · Traditional | 02/26/2016SE |
| K897086 | Parker Ambulatory Medication Infusion Pump 2004FRN · Traditional | 09/28/1990SE |
| K834461 | Infusion Pump PrimerFRN · Traditional | 01/30/1984SE |
| K833723 | Model 2000 Ambulatory Med. InfuserFRN · Traditional | 01/30/1984SE |
Questions and answers
When was Modified Labeling to Model 2000 Ambulatory Infuser cleared by the FDA?
Modified Labeling to Model 2000 Ambulatory Infuser (K863532) received a 510(k) decision of Substantially Equivalent on January 14, 1987, 127 days after the submission was received.
What is the product code of K863532?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.