Volumetric Infusion Pump, Modification
FDA 510(k) K913056 · Mcgaw, Inc.
510(k) numberK913056
Submission
- Device name
- Volumetric Infusion Pump, Modification
- Applicant
- Mcgaw, Inc.
Irvine, CA, US - Received
- July 2, 1991
- Decision date
- September 6, 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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| K932856 | Irrigation Access CapFPA · Traditional | 01/26/1994SE |
| K922637 | Horizon Pump Y-Type Blood SetFPA · Traditional | 06/04/1993SE |
| K921860 | Modification to IV SpikeFPA · Traditional | 07/30/1992SE |
| K913661 | Modified Volumetric Infusion PumpFRN · Traditional | 12/18/1991SE |
Questions and answers
When was Volumetric Infusion Pump, Modification cleared by the FDA?
Volumetric Infusion Pump, Modification (K913056) received a 510(k) decision of Substantially Equivalent on September 6, 1991, 66 days after the submission was received.
What is the product code of K913056?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.