510(k) K980960
K980960 is an FDA 510(k) premarket notification submitted by Clement Clarke Intl., Ltd. for the device "IN-CHECK INSPIRATORY FLOWMETER". The FDA issued a decision of Substantially Equivalent on Jun 10, 1998. 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
- Jun 10, 1998
- Date Received
- Mar 16, 1998
- 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)