510(k) K945970
K945970 is an FDA 510(k) premarket notification submitted by Xylog Corp. for the device "INSUFFLATOR FILTER TUBING SET". The FDA issued a decision of Substantially Equivalent on December 15, 1994. The device falls under product code FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope), a Class II device regulated under 21 CFR 876.1500. Xylog Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 1994
- Date Received
- December 8, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insufflator, Automatic Carbon-Dioxide For Endoscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type