Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70XX, 71XX, 72XX, 7XXXX Series
FDA 510(k) K032147 · Alaris Medical Systems, Inc.
510(k) numberK032147
Submission
- Device name
- Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70XX, 71XX, 72XX, 7XXXX Series
- Applicant
- Alaris Medical Systems, Inc.
San Diego, CA, US - Received
- July 14, 2003
- Decision date
- July 25, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K032233 | Medley Pca Module, Model 8120MEA · Traditional | 09/09/2003SE |
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| K023264 | Medley Syringe Pump Module System, Model 8110FRN · Traditional | 12/19/2002SE |
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| K013087 | Single Dose Dispensing Pin, Model 2201LHI · Traditional | 11/13/2001SE |
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Questions and answers
When was Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70XX, 71XX, 72XX, 7XXXX Series cleared by the FDA?
Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70XX, 71XX, 72XX, 7XXXX Series (K032147) received a 510(k) decision of Substantially Equivalent on July 25, 2003, 11 days after the submission was received.
What is the product code of K032147?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.