Disposable CO2 Gas Sampling/Oxygen Delivery Cannul
FDA 510(k) K915228 · Hospitak, Inc.
510(k) numberK915228
Submission
- Device name
- Disposable CO2 Gas Sampling/Oxygen Delivery Cannul
- Applicant
- Hospitak, Inc.
Lindenhurst, NY, US - Received
- November 20, 1991
- Decision date
- February 11, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
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More from Southmedic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K955483 | Trach Mask Model (245, 246)BYF · Traditional | 02/28/1996SE |
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| K953620 | Warm N Wet Hmef W/Luer AdapterBYD · Traditional | 08/25/1995SE |
| K953619 | Warm N Wet Hme W/Luer AdapterBYD · Traditional | 08/25/1995SE |
| K915750 | Disposable Bacterial Breathng FilterCAH · Traditional | 11/30/1994SE |
| K920842 | Aerosol Delivery SystemsLRD · Traditional | 05/15/1992SE |
| K873286 | Disposable, Manual Pulmonary ResuscitatorBTM · Traditional | 10/26/1987SE |
| K853600 | Inflatable Air SplintsFZF · Traditional | 09/19/1985SE |
| K844328 | Oxygen ConcentratorCAW · Traditional | 12/04/1984SE |
| K843212 | Low Pressure Alarm for Oxygen CylinderBXH · Traditional | 09/19/1984SE |
Questions and answers
When was Disposable CO2 Gas Sampling/Oxygen Delivery Cannul cleared by the FDA?
Disposable CO2 Gas Sampling/Oxygen Delivery Cannul (K915228) received a 510(k) decision of Substantially Equivalent on February 11, 1992, 83 days after the submission was received.
What is the product code of K915228?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.