Model 2 Flowmeter
FDA 510(k) K810132 · Harris Calorific
510(k) numberK810132
Submission
- Device name
- Model 2 Flowmeter
- Applicant
- Harris Calorific
Walker, MI, US - Received
- January 19, 1981
- Decision date
- January 28, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K936187 | Lspi Pressure RegulatorCAN · Traditional | Life Support Products, Inc. | 01/27/1994SE |
| K932006 | 1500 Series RegulatorCAN · Traditional | Precision Medical, Inc. | 10/25/1993SE |
| 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 |
More from C.G.H. Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K791648 | Model 54 Flowmeter Back-Pressure TubeCAX · Traditional | 09/17/1979SE |
Questions and answers
When was Model 2 Flowmeter cleared by the FDA?
Model 2 Flowmeter (K810132) received a 510(k) decision of Substantially Equivalent on January 28, 1981, 9 days after the submission was received.
What is the product code of K810132?
The FDA product code is CAN – Regulator, Pressure, Gas Cylinder, a Class I (low risk) device regulated under 21 CFR 868.2700.