Ivac Space Saver Volumetric Pump, Model 599
FDA 510(k) K932544 · Y
510(k) numberK932544
Submission
- Device name
- Ivac Space Saver Volumetric Pump, Model 599
- Applicant
- Y
San Diego, CA, US - Received
- May 26, 1993
- Decision date
- October 12, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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More from Deka Research and Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K955846 | Model 2082 Temp Plus III Thermometer/Model 2087 Temp Plus III Wall Mount ThermometerFLL · Traditional | 10/01/1996SE |
| K960280 | Ivac Needle Free Valve Administration SetsFPA · Traditional | 04/04/1996SE |
| K953225 | Ivac Ball Valce Admin. SetsFPA · Traditional | 09/27/1995SE |
| K934095 | Ivac Vented Syringe Adapter Administration SetsFPA · Traditional | 08/10/1994SE |
| K940897 | Ivac Needleless Infection Valve Administration SetFPA · Traditional | 06/22/1994SE |
| K931550 | Ez Administration SetFPA · Traditional | 01/10/1994SE |
| K931549 | Model EZ-1 Sing CHAN/EZ-2 Dual Channel Infus PumpFRN · Traditional | 10/12/1993SE |
| K922115 | Ivac Needleless Injection ValveFPA · Traditional | 10/12/1993SE |
| K930781 | Infusion PumpFRN · Traditional | 08/19/1993SE |
| K925228 | Ivac 59 Series Universal Set W/ Anti-Free Flow ValFPA · Traditional | 07/30/1993SE |
Questions and answers
When was Ivac Space Saver Volumetric Pump, Model 599 cleared by the FDA?
Ivac Space Saver Volumetric Pump, Model 599 (K932544) received a 510(k) decision of Substantially Equivalent on October 12, 1993, 139 days after the submission was received.
What is the product code of K932544?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.