SOFNOLIME CARBON DIOXIDE ABSORBENT
FDA 510(k) clearance K921803 · decided 1992-10-15
Clearance details
- K-number
- K921803
- Device name
- SOFNOLIME CARBON DIOXIDE ABSORBENT
- Applicant
- Molecular Products , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1992-04-15
- Decision date
- 1992-10-15
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- CBL
- Device class
- 1
- Regulation number
- 868.5300
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Thaxted, Essex, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE CO2 ABSORBER/E (K897171) | Gibeck, Inc. | 1990-03-13 |
| CARBON DIOXIDE ABSORBENTS (K860147) | Dentsply Intl. | 1986-02-28 |
| MEDIPART SODA LIME MP-3522 (K853571) | Medipart Jerry Alexander | 1985-10-29 |
| BARALYME CO2 ABSORBENT (K811260) | Allied Healthcare Products, Inc. | 1981-05-27 |
Recalls involving this device
No recalls on record reference this clearance.