Volume Control Device VCD-150
FDA 510(k) K780465 · Sorensen Research
510(k) numberK780465
Submission
- Device name
- Volume Control Device VCD-150
- Applicant
- Sorensen Research
Walker, MI, US - Received
- March 22, 1978
- Decision date
- June 2, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KZD – Infusor, Pressure, For I.V. Bags
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5420
- Specialty
- General Hospital
Other 510(k)s with product code KZD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974074 | Infusion Dynamics Power InfuserKZD · Traditional | Infusion Dynamics, Inc. | 02/17/1998SE |
| K973843 | Msi Pressure InfusorKZD · Traditional | Smith Assoc. | 10/29/1997SE |
| K953290 | Olympus Automatic Surgical Irrigation PumpKZD · Traditional | Olympus America, Inc. | 10/07/1995SE |
| K951988 | PressurizerKZD · Traditional | Promedic, Inc. | 06/14/1995SE |
| K942933 | Pressure Infusion CuffKZD · Traditional | Circulatory Technology, Inc. | 08/25/1994SE |
| K930012 | Kawasumi Laboratories K-CuffKZD · Traditional | Kawasumi Laboratories Co., Ltd. | 12/14/1993SE |
| K921168 | Allen Infusion Pump Model 3000 and Irrigation 2000KZD · Traditional | Allen Medical Systems, Inc. | 04/21/1993SE |
| K913751 | Pressure InfuserKZD · Traditional | Biomedical Dynamics, Inc. | 01/09/1992SE |
| K910926 | Tecnadyne Surgi-Squeeze Infusion PumpKZD · Traditional | Tecnadyne Scientific, Inc. | 08/02/1991SE |
| K911216 | InfusableKZD · Traditional | Biomedical Dynamics, Inc. | 07/22/1991SE |
More from Biomedical Dynamics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K833674 | Accurate Measurement Device Kg-AmdGCX · Traditional | 01/25/1984SE |
| K833673 | Accurate Measurement Device Ez-AmdGCX · Traditional | 12/29/1983SE |
| K833096 | Transducer Dome DS106DRS · Traditional | 11/03/1983SE |
| K833095 | Transducer Dome SD105DRS · Traditional | 11/03/1983SE |
| K833094 | Transducer Dome SD104DRS · Traditional | 11/03/1983SE |
| K832957 | Flow-Directed Heparin Coated ThermodilDYG · Traditional | 09/29/1983SE |
| K831506 | Disp. Transducer W/Monitoring Kit TransDRS · Traditional | 08/12/1983SE |
| K831939 | Tall Floor Stand TFS-01GCX · Traditional | 07/19/1983SE |
| K831505 | Thoracic Gauge #TG-60 -Vacuum RegulatorKDP · Traditional | 07/12/1983SE |
| K820706 | Waterless Seal & Vacuum RegulatorKDP · Traditional | 04/09/1982SE |
Questions and answers
When was Volume Control Device VCD-150 cleared by the FDA?
Volume Control Device VCD-150 (K780465) received a 510(k) decision of Substantially Equivalent on June 2, 1978, 72 days after the submission was received.
What is the product code of K780465?
The FDA product code is KZD – Infusor, Pressure, For I.V. Bags, a Class I (low risk) device regulated under 21 CFR 880.5420.