Medrad Intego PET Infusion System
FDA 510(k) K080297 · Medrad, Inc.
510(k) numberK080297
Submission
- Device name
- Medrad Intego PET Infusion System
- Applicant
- Medrad, Inc.
Indianola, PA, US - Received
- February 4, 2008
- Decision date
- June 17, 2008
- 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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| K100798 | Medrad Intego PET Infusion System, Source Administration Set, Patient Adminstratin Set…FRN · Traditional | 06/23/2010SE |
Questions and answers
When was Medrad Intego PET Infusion System cleared by the FDA?
Medrad Intego PET Infusion System (K080297) received a 510(k) decision of Substantially Equivalent on June 17, 2008, 134 days after the submission was received.
What is the product code of K080297?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.