Regulator Flowmeter
FDA 510(k) K915505 · Lifeguard Medical Products, Inc.
510(k) numberK915505
Submission
- Device name
- Regulator Flowmeter
- Applicant
- Lifeguard Medical Products, Inc.
Indianapolis, IN, US - Received
- December 9, 1991
- Decision date
- April 22, 1992
- 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
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| K880958 | Lifeguard Bacterial and Viral FilterCAH · Traditional | 04/27/1988SE |
| K881087 | Lifeguard Single Use Manual ResuscitatorsBTM · Traditional | 04/14/1988SE |
| K881086 | Lifeguard Mouth to Mask ResuscitatorBTM · Traditional | 04/14/1988SE |
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| K863711 | Regulator Oxygen MechanicalCAN · Traditional | 01/27/1987SE |
Questions and answers
When was Regulator Flowmeter cleared by the FDA?
Regulator Flowmeter (K915505) received a 510(k) decision of Substantially Equivalent on April 22, 1992, 135 days after the submission was received.
What is the product code of K915505?
The FDA product code is CAN – Regulator, Pressure, Gas Cylinder, a Class I (low risk) device regulated under 21 CFR 868.2700.