510(k) K142155
K142155 is an FDA 510(k) premarket notification submitted by Endochoice, Inc. for the device "ENDOCHOICE WATER BOTTLE CAP SYSTEM". The FDA issued a decision of Substantially Equivalent on January 20, 2015. The device falls under product code FEQ (Pump, Air, Non-Manual, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Endochoice, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 20, 2015
- Date Received
- August 6, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Air, Non-Manual, For Endoscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type