Flo-Gard 6200 Volumetric Infusion/Pumping Blood
FDA 510(k) K870801 · Travenol Laboratories, S.A.
510(k) numberK870801
Submission
- Device name
- Flo-Gard 6200 Volumetric Infusion/Pumping Blood
- Applicant
- Travenol Laboratories, S.A.
Round Lake, IL, US - Received
- February 27, 1987
- Decision date
- September 4, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K871471 | Capillary Flow Dialyzers Models ST-12 & ST-15FJI · Traditional | 06/12/1987SE |
| K865029 | Continu-Flo Solution Admin. Set W/In-Line FilterFPB · Traditional | 04/17/1987SE |
| K870169 | Capillary Flow DialyzersFJI · Traditional | 04/06/1987SE |
Questions and answers
When was Flo-Gard 6200 Volumetric Infusion/Pumping Blood cleared by the FDA?
Flo-Gard 6200 Volumetric Infusion/Pumping Blood (K870801) received a 510(k) decision of Substantially Equivalent on September 4, 1987, 189 days after the submission was received.
What is the product code of K870801?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.