Disposable CO2 Absorber/E
FDA 510(k) K897171 · Gibeck, Inc.
510(k) numberK897171
Submission
- Device name
- Disposable CO2 Absorber/E
- Applicant
- Gibeck, Inc.
Indianapolis, IN, US - Received
- December 28, 1989
- Decision date
- March 13, 1990
- 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 |
| K860147 | Carbon Dioxide AbsorbentsCBL · Traditional | Dentsply Intl. | 02/28/1986SE |
| 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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| K952845 | Humid-Vent Trach-VentBYD · Traditional | 07/25/1995SE |
| K952844 | Humid-Vent 2BYD · Traditional | 07/20/1995SE |
| K952750 | Humid-Vent 1BYD · Traditional | 07/20/1995SE |
Questions and answers
When was Disposable CO2 Absorber/E cleared by the FDA?
Disposable CO2 Absorber/E (K897171) received a 510(k) decision of Substantially Equivalent on March 13, 1990, 75 days after the submission was received.
What is the product code of K897171?
The FDA product code is CBL – Absorbent, Carbon-Dioxide, a Class I (low risk) device regulated under 21 CFR 868.5300.