510(k) K935059
K935059 is an FDA 510(k) premarket notification submitted by Phx Technologies Corp. for the device "INSUFFLATION TUBING SET, PHX500-082". The FDA issued a decision of Substantially Equivalent on Dec 22, 1993. The device falls under product code FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope), a Class II device regulated under 21 CFR 876.1500. Phx Technologies Corp. has 48 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 22, 1993
- Date Received
- Oct 21, 1993
- 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
- 510(k)