510(k) K011668
K011668 is an FDA 510(k) premarket notification submitted by Oridion Medical 1987 , Ltd. for the device "VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI". The FDA issued a decision of Substantially Equivalent on July 9, 2001. The device falls under product code MSQ (Test, Urea (Breath Or Blood)), a Class I device regulated under 21 CFR 866.3110. Oridion Medical 1987 , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 2001
- Date Received
- May 17, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Urea (Breath Or Blood)
- Device Class
- Class I
- Regulation Number
- 866.3110
- Review Panel
- MI
- Submission Type