510(k) K053156
K053156 is an FDA 510(k) premarket notification submitted by Clement Clarke Intl., Ltd. for the device "MINI-WRIGHT DIGITAL, MODEL 3120001". The FDA issued a decision of Substantially Equivalent on Jan 31, 2006. The device falls under product code BZH (Meter, Peak Flow, Spirometry), a Class II device regulated under 21 CFR 868.1860. Clement Clarke Intl., Ltd. has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 31, 2006
- Date Received
- Nov 14, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Meter, Peak Flow, Spirometry
- Device Class
- Class II
- Regulation Number
- 868.1860
- Review Panel
- AN
- Submission Type
- 510(k)