Flowlock Oxygen Meter
FDA 510(k) K811162 · Lifeguard Medical Products, Inc.
510(k) numberK811162
Submission
- Device name
- Flowlock Oxygen Meter
- Applicant
- Lifeguard Medical Products, Inc.
Mchenry, IL, US - Received
- April 28, 1981
- Decision date
- May 8, 1981
- 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
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| 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 |
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| K880958 | Lifeguard Bacterial and Viral FilterCAH · Traditional | 04/27/1988SE |
| K881087 | Lifeguard Single Use Manual ResuscitatorsBTM · Traditional | 04/14/1988SE |
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Questions and answers
When was Flowlock Oxygen Meter cleared by the FDA?
Flowlock Oxygen Meter (K811162) received a 510(k) decision of Substantially Equivalent on May 8, 1981, 10 days after the submission was received.
What is the product code of K811162?
The FDA product code is BYJ – Unit, Liquid-Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5655.