510(k) K051712
K051712 is an FDA 510(k) premarket notification submitted by Air Safety, Ltd. for the device "MODEL 2800 PFT FILTER". The FDA issued a decision of Substantially Equivalent on September 1, 2005. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Air Safety, Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 1, 2005
- Date Received
- June 27, 2005
- 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