Ivac(R) Space.saver(Tm) Volumetric Pump Model 599
by Y
510(k) K894037
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK894037 | Date28 Aug 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FRN
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5725
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Ivac Space Saver Volumetric Pump Model 599 is a pump, infusion device. It is classified as a Class 2 device with the product code FRN. The device is used for infusion purposes in a general hospital setting.
The device is supplied by Y and has been cleared by the FDA with the 510(k) number K894037. It is a non-single use device, and its regulation number is 880.5725. The device was cleared on August 28, 1989.
Other devices from Y
Questions
AI-generated answers, 21 Sep 2026
What is the Ivac Space Saver Volumetric Pump Model 599 used for?
The Ivac Space Saver Volumetric Pump Model 599 is used for infusion purposes in a general hospital setting.
Is the Ivac Space Saver Volumetric Pump Model 599 a single-use device?
No, the Ivac Space Saver Volumetric Pump Model 599 is a non-single use device.
What is the regulatory classification of the Ivac Space Saver Volumetric Pump Model 599?
The Ivac Space Saver Volumetric Pump Model 599 is classified as a Class 2 device with the product code FRN and regulation number 880.5725.