510(k) K000314
K000314 is an FDA 510(k) premarket notification submitted by Engineered Medical Systems for the device "INCENTIVE SPIROMETER". The FDA issued a decision of Substantially Equivalent on April 12, 2000. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. Engineered Medical Systems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 2000
- Date Received
- February 1, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spirometer, Therapeutic (Incentive)
- Device Class
- Class II
- Regulation Number
- 868.5690
- Review Panel
- AN
- Submission Type