Protege Liquid Oxygen System
FDA 510(k) K971545 · Healthdyne Technologies, Inc.
510(k) numberK971545
Submission
- Device name
- Protege Liquid Oxygen System
- Applicant
- Healthdyne Technologies, Inc.
Indianapolis, IN, US - Received
- April 28, 1997
- Decision date
- July 25, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BYJ – Unit, Liquid-Oxygen, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5655
- Specialty
- Anesthesiology
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| 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.
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|---|---|---|
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| K974879 | Model 7410 VoyagerBZD · Traditional | 06/29/1998SE |
| K972614 | Twister Oxygen Concentrator Model 600, Twister Oxygen Concentrator W/Opi Model 605CAW · Traditional | 01/20/1998SE |
| K971867 | Alice 4R SystemOLV · Traditional | 08/13/1997SE |
| K970173 | Model 1700 Tranquility Bilevel SystemBZD · Traditional | 04/16/1997SE |
| K962517 | Model 7700 Quantum Pressure Support Ventilator PSVMNS · Traditional | 02/20/1997SE |
| K943509 | 7300 Nasal CPAP SystemBZD · Traditional | 08/05/1994SE |
Questions and answers
When was Protege Liquid Oxygen System cleared by the FDA?
Protege Liquid Oxygen System (K971545) received a 510(k) decision of Substantially Equivalent on July 25, 1997, 88 days after the submission was received.
What is the product code of K971545?
The FDA product code is BYJ – Unit, Liquid-Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5655.