510(k) K103025
K103025 is an FDA 510(k) premarket notification submitted by Given Imaging , Ltd. for the device "GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES". The FDA issued a decision of Substantially Equivalent on May 13, 2011. The device falls under product code NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule), a Class II device regulated under 21 CFR 876.1300. Given Imaging , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 2011
- Date Received
- October 12, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Gastrointestinal, Wireless, Capsule
- Device Class
- Class II
- Regulation Number
- 876.1300
- Review Panel
- GU
- Submission Type