Liberator/Stroller
FDA 510(k) K760787 · Burditt & Calkins-Siemens-Elema
510(k) numberK760787
Submission
- Device name
- Liberator/Stroller
- Applicant
- Burditt & Calkins-Siemens-Elema
Mchenry, IL, US - Received
- October 6, 1976
- Decision date
- October 22, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BYJ – Unit, Liquid-Oxygen, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5655
- Specialty
- Anesthesiology
Other 510(k)s with product code BYJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K130068 | Dismounted Medical & Supplemental Oxygen System (Dmos)BYJ · Traditional | Essex Industries, Inc. D/B/A Essex Cryogenics of M | 07/19/2013SE |
| K113767 | Mounted Medical Oxygen SystemBYJ · Traditional | Essex Industries, Inc. | 06/29/2012SE |
| K103324 | Precision Liquid Oxygen SystemBYJ · Traditional | Precision Medical, Inc. | 04/21/2011SE |
| K101272 | Mass Oxygen Distribution System (Mods) Model 10C-0061-3BYJ · Traditional | Essex Industries, Inc. | 08/20/2010SE |
| K081779 | GOLOX-93BYJ · Traditional | Respironics, Inc. | 09/19/2008SE |
| K080023 | Modification to: SpiritBYJ · Special | Caire, Inc. | 06/16/2008SE |
| K072723 | Respironics GoloxBYJ · Traditional | Respironics, Inc. | 03/20/2008SE |
| K072011 | Copd Liquid Oxygen Portable, Model 300PBYJ · Traditional | Copd Partners, Inc. | 10/18/2007SE |
| K071581 | Backpack Medical Oxygen SystemBYJ · Traditional | Essex Cryogenics of Missouri, Inc. | 07/11/2007SE |
| K050153 | Spirit, Model HasBYJ · Traditional | Caire, Inc. | 04/15/2005SE |
More from Caire, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K833519 | Pulse Generator Model 688DXY · Traditional | 01/30/1984SE |
| K833155 | Rayden Medical Mini Pulse Volume RecordDSB · Traditional | 01/26/1984SE |
| K830344 | Siemens-Elma Pulse Generator #718DXY · Traditional | 05/27/1983SE |
| K823435 | Mon-A-Therm Myocardial Temp. SensorKRB · Traditional | 12/30/1982SE |
| K823591 | Ameda Hand Breast PumpHGY · Traditional | 12/28/1982SE |
| K822239 | Coaxial Bipolar Pacing ElectrodeDTB · Traditional | 10/04/1982SE |
| K821712 | Informed Remote Field Unit Model IFM1000BTY · Traditional | 07/26/1982SE |
| K803111 | ErectaidFAE · Traditional | 01/23/1981SE |
| K802607 | Terperatur Sensing DeviceFLL · Traditional | 11/19/1980SE |
Questions and answers
When was Liberator/Stroller cleared by the FDA?
Liberator/Stroller (K760787) received a 510(k) decision of Substantially Equivalent on October 22, 1976, 16 days after the submission was received.
What is the product code of K760787?
The FDA product code is BYJ – Unit, Liquid-Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5655.