FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
SOFNOLIME CARBON DIOXIDE ABSORBENT
K Number: K921803
·
Decision Oct 15, 1992
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
4
Applicant Total
4
Review Days
183
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Basic Information
- Device Name
- SOFNOLIME CARBON DIOXIDE ABSORBENT
- K Number
- K921803
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5300
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Molecular Products , Ltd.
- Date Received
- April 15, 1992
- Decision Date
- October 15, 1992
- Product Code
- CBL
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CBL | Absorbent, Carbon-Dioxide | FDA class 1 | Anesthesiology |
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