Koala C99 I.V. Controller
FDA 510(k) K830780 · Chesebrough-Pond'S U.S.A. Co.
510(k) numberK830780
Submission
- Device name
- Koala C99 I.V. Controller
- Applicant
- Chesebrough-Pond'S U.S.A. Co.
Mchenry, IL, US - Received
- March 11, 1983
- Decision date
- April 8, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LDR – Controller, Infusion, Intravascular, Electronic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K851382 | Chesebrough-Pond's Sequential Wound DressingNAD · Traditional | 07/05/1985SN |
| K851539 | Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap CloKNT · Traditional | 06/12/1985SE |
| K843567 | Kangaroo Nasogastric Feeding TubeKNT · Traditional | 02/14/1985SE |
| K845010 | Chesebrough-Pond's Uri-Drain Male Urinary PouchEYQ · Traditional | 01/15/1985SE |
| K844186 | Continent Stoma System & AccessoriesKBG · Traditional | 01/15/1985SE |
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| K843128 | Female Urinary Incontinence SysKNX · Traditional | 01/02/1985SE |
Questions and answers
When was Koala C99 I.V. Controller cleared by the FDA?
Koala C99 I.V. Controller (K830780) received a 510(k) decision of Substantially Equivalent on April 8, 1983, 28 days after the submission was received.
What is the product code of K830780?
The FDA product code is LDR – Controller, Infusion, Intravascular, Electronic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.