FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE CO2 ABSORBER/E
K Number: K897171
·
Decision Mar 13, 1990
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
4
Applicant Total
15
Review Days
75
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Basic Information
- Device Name
- DISPOSABLE CO2 ABSORBER/E
- K Number
- K897171
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5300
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Gibeck, Inc.
- Date Received
- December 28, 1989
- Decision Date
- March 13, 1990
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CBL), ordered by most recent decision date.
SOFNOLIME CARBON DIOXIDE ABSORBENT
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FDA Class 1
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CARBON DIOXIDE ABSORBENTS
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FDA Class 1
·Anesthesiology
MEDIPART SODA LIME MP-3522
FDA 510(k)
FDA Class 1
·Anesthesiology
BARALYME CO2 ABSORBENT
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Gibeck, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K965016 | ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212) | Dec 2, 1997 | Substantially Equivalent |
| K964377 | THERMAL REGULATION SYSTEM BLANKET | Apr 23, 1997 | Substantially Equivalent |
| K964382 | HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402) | Apr 15, 1997 | Substantially Equivalent |
| K960511 | GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET | Jan 13, 1997 | Substantially Equivalent |
| K954828 | ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT | May 2, 1996 | Substantially Equivalent |
| K953544 | HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT | Aug 25, 1995 | Substantially Equivalent |
| K953491 | HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE | Aug 25, 1995 | Substantially Equivalent |
| K952845 | HUMID-VENT TRACH-VENT | Jul 25, 1995 | Substantially Equivalent |
| K952844 | HUMID-VENT 2 | Jul 20, 1995 | Substantially Equivalent |
| K952750 | HUMID-VENT 1 | Jul 20, 1995 | Substantially Equivalent |