510(k) K042058
K042058 is an FDA 510(k) premarket notification submitted by Clement Clarke Intl., Ltd. for the device "ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN". The FDA issued a decision of Substantially Equivalent on Mar 23, 2005. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Clement Clarke Intl., Ltd. has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 23, 2005
- Date Received
- Jul 30, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Spirometer, Diagnostic
- Device Class
- Class II
- Regulation Number
- 868.1840
- Review Panel
- AN
- Submission Type
- 510(k)