Adfuse(Tm)
FDA 510(k) K881590 · Healthtek, Inc.
510(k) numberK881590
Submission
- Device name
- Adfuse(Tm)
- Applicant
- Healthtek, Inc.
Nevada City, CA, US - Received
- April 13, 1988
- Decision date
- May 23, 1988
- 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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More from Deka Research and Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K923448 | Empty Solution Transfer Container W/ Detach LegKPE · Traditional | 07/28/1993SE |
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| K913608 | SnapperKPE · Traditional | 11/29/1991SE |
| K874495 | Adcomp 4000 HP SystemLHI · Traditional | 02/16/1988SE |
| K873848 | Retrobulbar NeedleGDM · Traditional | 10/23/1987SE |
| K860610 | AdcompLHI · Traditional | 07/08/1986SE |
| K860372 | Fast Flow XX (Aqueous Solution Filter)FPB · Traditional | 05/30/1986SE |
| K854008 | StatlockLHI · Traditional | 11/13/1985SE |
Questions and answers
When was Adfuse(Tm) cleared by the FDA?
Adfuse(Tm) (K881590) received a 510(k) decision of Substantially Equivalent on May 23, 1988, 40 days after the submission was received.
What is the product code of K881590?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.