510(k) K012368
K012368 is an FDA 510(k) premarket notification submitted by Trudell Medical Intl. for the device "AEROPEP". The FDA issued a decision of Substantially Equivalent on Feb 12, 2002. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. Trudell Medical Intl. has 11 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 12, 2002
- Date Received
- Jul 26, 2001
- 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
- 510(k)