510(k) K133722
K133722 is an FDA 510(k) premarket notification submitted by Eresearch Technology for the device "ASTHMA MONITOR AM3". The FDA issued a decision of Substantially Equivalent on May 8, 2014. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Eresearch Technology has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 2014
- Date Received
- December 5, 2013
- 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