PMS-2 Pressure Monitor Separator
FDA 510(k) K820912 · Delta Medical Industries
510(k) numberK820912
Submission
- Device name
- PMS-2 Pressure Monitor Separator
- Applicant
- Delta Medical Industries
Walker, MI, US - Received
- April 1, 1982
- Decision date
- May 18, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXS – Gauge, Pressure, Coronary, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4310
- Specialty
- Cardiovascular
Other 510(k)s with product code DXS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K113235 | Pressure Display Box,Dlp Disposable Pressure Display Sets-Non Sterile VersionsDXS · Special | Medtronic, Inc. | 12/02/2011SE |
| K944764 | Vti Disposable Pressure Display SetDXS · Traditional | Vascular Technology Incorporated | 12/27/1994SE |
| K912045 | TMP Pressure Isolatorr, TMP Pressure Monitor SystDXS · Traditional | Lifestream Int'L, Inc. | 10/31/1991SE |
| K900797 | Stockert Shiley Dual Pressure Control Module XRDXS · Traditional | Shiley, Inc. | 05/10/1990SE |
| K873802 | Pressure Barrier Kit Cat. No. PBK-3DXS · Traditional | American Omni Medical, Inc. | 11/06/1987SE |
| K862836 | Stockert-Shiley Caps and Caps Dual Pressure ModuleDXS · Traditional | Shiley, Inc. | 09/12/1986SE |
| K852232 | Pressure Display Box #60000/TUBING Set #61000DXS · Traditional | Dlp, Inc. | 08/09/1985SE |
| K842194 | Pressure MonitorDXS · Traditional | Norton Texas Medical Products | 08/27/1984SE |
| K831750 | PM-3DXS · Traditional | Delta Medical Industries | 07/26/1983SE |
| K822822 | Gambro Pressure Monitor PRM 10DXS · Traditional | Gambro, Inc. | 10/18/1982SE |
More from Gambro, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K833884 | Isotec Dispos. Pressure Transducer · Traditional | 04/17/1984SE |
| K840253 | One-Way Air ValveBYZ · Traditional | 04/05/1984SE |
| K832470 | Infusion PumpFRN · Traditional | 02/28/1984SE |
| K830389 | Accu-Rynge Pump SP-250FRN · Traditional | 09/12/1983SE |
| K831750 | PM-3DXS · Traditional | 07/26/1983SE |
| K822761 | Delivery Tube Set #2226FRN · Traditional | 09/30/1982SE |
| K820482 | Accu-Rynge Insulin Pump #SP-250FRN · Traditional | 03/26/1982SE |
| K810068 | Pediatric Arterial Blood FilterDTM · Traditional | 01/22/1981SE |
| K802755 | Arterial Blood Filter BF-37DTM · Traditional | 01/07/1981SE |
| K803102 | Arterial Bubble Trap K-20KRL · Traditional | 12/22/1980SE |
Questions and answers
When was PMS-2 Pressure Monitor Separator cleared by the FDA?
PMS-2 Pressure Monitor Separator (K820912) received a 510(k) decision of Substantially Equivalent on May 18, 1982, 47 days after the submission was received.
What is the product code of K820912?
The FDA product code is DXS – Gauge, Pressure, Coronary, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4310.