510(k) K183479
K183479 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 October 3, 2019. 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
- October 3, 2019
- Date Received
- December 17, 2018
- Clearance Type
- Special
- 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