1500 Series Regulator
FDA 510(k) K932006 · Precision Medical, Inc.
510(k) numberK932006
Submission
- Device name
- 1500 Series Regulator
- Applicant
- Precision Medical, Inc.
Northampton, PA, US - Received
- April 21, 1993
- Decision date
- October 25, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CAN – Regulator, Pressure, Gas Cylinder
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.2700
- Specialty
- Anesthesiology
Other 510(k)s with product code CAN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162811 | MR Conditional CGA 870CAN · Traditional | Essex Industries, Inc. | 03/02/2017SE |
| K080243 | Portable Oxygen Unit SCA900CAN · Traditional | San Cheong Co. , Ltd. | 04/07/2009SE |
| K060265 | Remcore Remote Controlled Oxygen RegulatorCAN · Traditional | Remcore, Inc. | 10/25/2006SE |
| K061785 | Cyl-Fil Oxygen SystemCAN · Traditional | Responsive Respiratory, Inc. | 09/07/2006SE |
| K950777 | Oxygen RegulatorCAN · Traditional | Mada Medical Products, Inc. | 04/14/1995SE |
| K942751 | Vanguard Series Gas RegulatorsCAN · Traditional | Buckman Co., Inc. | 02/09/1995SE |
| K936187 | Lspi Pressure RegulatorCAN · Traditional | Life Support Products, Inc. | 01/27/1994SE |
| K921125 | Ambu Oxygen RegulatorCAN · Traditional | Amg, LLC | 09/17/1992SE |
| K915154 | Gambro Engstrom Y Filter Pkg. Alone W/ Var.ModelsCAN · Traditional | C.G.H. Medical, Inc. | 05/27/1992SE |
| K915505 | Regulator FlowmeterCAN · Traditional | Lifeguard Medical Products, Inc. | 04/22/1992SE |
More from Lifeguard Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K173807 | Accu O2 Oxygen AnalyzerCCL · Abbreviated | 05/02/2018SE |
| K140179 | Easy Go VacBTA · Special | 04/25/2014SE |
| K103563 | Precision Portable Oxygen Concentration Model 4150CAW · Traditional | 07/01/2011SE |
| K103324 | Precision Liquid Oxygen SystemBYJ · Traditional | 04/21/2011SE |
| K090781 | HELIO2 BlenderBZR · Traditional | 08/13/2009SE |
| K072348 | Precision Oxygen ConcentratorCAW · Abbreviated | 10/27/2008SE |
| K063096 | Precision Oxygen MonitorCCL · Abbreviated | 02/27/2007SE |
| K053232 | Precision BlenderBZR · Traditional | 01/10/2006SE |
| K051691 | Minimate CompressorBTI · Traditional | 12/09/2005SE |
| K041122 | Precision Liquid Oxygen SystemBYJ · Traditional | 10/04/2004SE |
Questions and answers
When was 1500 Series Regulator cleared by the FDA?
1500 Series Regulator (K932006) received a 510(k) decision of Substantially Equivalent on October 25, 1993, 187 days after the submission was received.
What is the product code of K932006?
The FDA product code is CAN – Regulator, Pressure, Gas Cylinder, a Class I (low risk) device regulated under 21 CFR 868.2700.