510(k) K897171
K897171 is an FDA 510(k) premarket notification submitted by Gibeck, Inc. for the device "DISPOSABLE CO2 ABSORBER/E". The FDA issued a decision of Substantially Equivalent on March 13, 1990. The device falls under product code CBL (Absorbent, Carbon-Dioxide), a Class I device regulated under 21 CFR 868.5300. Gibeck, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 1990
- Date Received
- December 28, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Absorbent, Carbon-Dioxide
- Device Class
- Class I
- Regulation Number
- 868.5300
- Review Panel
- AN
- Submission Type