Rateminder(Tm) V Infusion Pump, Modification
FDA 510(k) K911769 · Critikon Company, LLC
510(k) numberK911769
Submission
- Device name
- Rateminder(Tm) V Infusion Pump, Modification
- Applicant
- Critikon Company, LLC
Tampa, FL, US - Received
- April 19, 1991
- Decision date
- June 3, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K943709 | Dinamap Plus Vital Signs MonoitorDPS · Traditional | 06/16/1995SE |
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| K933050 | Changes to Protectiv(Tm) & Jelco(Tm) Winged CathFOZ · Traditional | 12/14/1993SE |
| K915697 | Critikon Vital Signs ModuleDXN · Traditional | 07/01/1993SE |
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Questions and answers
When was Rateminder(Tm) V Infusion Pump, Modification cleared by the FDA?
Rateminder(Tm) V Infusion Pump, Modification (K911769) received a 510(k) decision of Substantially Equivalent on June 3, 1991, 45 days after the submission was received.
What is the product code of K911769?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.