510(k) K112173
K112173 is an FDA 510(k) premarket notification submitted by Spacelabs Healthcare for the device "SPEACELABS MULTIGAS MODULE". The FDA issued a decision of Substantially Equivalent on October 5, 2011. The device falls under product code CBR (Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)), a Class II device regulated under 21 CFR 868.1700. Spacelabs Healthcare has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 2011
- Date Received
- July 28, 2011
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- Device Class
- Class II
- Regulation Number
- 868.1700
- Review Panel
- AN
- Submission Type