510(k) K811260
- Device
- BARALYME CO2 ABSORBENT
- Applicant
- ALLIED HEALTHCARE PRODUCTS, INC.
- 510(k) number
- K811260
- Product code
- CBL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-05-27
- Date received
- 1981-05-06
- Regulation
- 868.5300
- Classification name
- Absorbent, Carbon-dioxide
- Medical specialty
- Anesthesiology
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3002900281
- 3013557562
- 3016904853
- 8021995
- 9616692
- 1314798
- 3010187802
- 3009133183
- 3005367964
- 3012307300
- 1836161
- 3002807637
- 3010131137
- 3002807267
- 8030673
- 3030446844
- 3012542015
- 3013507143
- 3011417395
- 3008693658
- 3017434950
- 3010838917
- 3030733800
- 9611500
- 3013036322
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CBL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K921803 | SOFNOLIME CARBON DIOXIDE ABSORBENT | Molecular Products , Ltd. | 1992-10-15 |
| K897171 | DISPOSABLE CO2 ABSORBER/E | Gibeck, Inc. | 1990-03-13 |
| K860147 | CARBON DIOXIDE ABSORBENTS | Dentsply Intl. | 1986-02-28 |
| K853571 | MEDIPART SODA LIME MP-3522 | Medipart Jerry Alexander | 1985-10-29 |
Legacy Summary#
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FDA Review#
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