Carbon Dioxide Absorbents
FDA 510(k) K860147 · Dentsply Intl.
510(k) numberK860147
Submission
- Device name
- Carbon Dioxide Absorbents
- Applicant
- Dentsply Intl.
York, PA, US - Received
- January 15, 1986
- Decision date
- February 28, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CBL – Absorbent, Carbon-Dioxide
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5300
- Specialty
- Anesthesiology
Other 510(k)s with product code CBL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K921803 | Sofnolime Carbon Dioxide AbsorbentCBL · Traditional | Molecular Products , Ltd. | 10/15/1992SE |
| K897171 | Disposable CO2 Absorber/ECBL · Traditional | Gibeck, Inc. | 03/13/1990SE |
| K853571 | Medipart Soda Lime MP-3522CBL · Traditional | Medipart Jerry Alexander | 10/29/1985SE |
| K811260 | Baralyme CO2 AbsorbentCBL · Traditional | Allied Healthcare Products, Inc. | 05/27/1981SE |
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Questions and answers
When was Carbon Dioxide Absorbents cleared by the FDA?
Carbon Dioxide Absorbents (K860147) received a 510(k) decision of Substantially Equivalent on February 28, 1986, 44 days after the submission was received.
What is the product code of K860147?
The FDA product code is CBL – Absorbent, Carbon-Dioxide, a Class I (low risk) device regulated under 21 CFR 868.5300.