Periflux PF-2
FDA 510(k) K844631 · Medex, Inc.
510(k) numberK844631
Submission
- Device name
- Periflux PF-2
- Applicant
- Medex, Inc.
Hilliard, OH, US - Received
- November 27, 1984
- Decision date
- February 20, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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| K982640 | Medex 3000 Series Syringe Infusion PumpFRN · Traditional | 04/06/1999ST |
| K982123 | Contrast Control DeviceFPA · Traditional | 07/21/1998SE |
| K955231 | Medfusion Model 2001 Syringe Infusion PumpFRN · Traditional | 07/18/1996ST |
| K961404 | MX960 Reusable Pressure TransducerDRS · Traditional | 06/27/1996SE |
Questions and answers
When was Periflux PF-2 cleared by the FDA?
Periflux PF-2 (K844631) received a 510(k) decision of Substantially Equivalent on February 20, 1985, 85 days after the submission was received.
What is the product code of K844631?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.