510(k) K964130
K964130 is an FDA 510(k) premarket notification submitted by Monaghan Medical Corp. for the device "AEROGEAR ASTHMA ACTION KIT". The FDA issued a decision of Substantially Equivalent on January 10, 1997. The device falls under product code BZH (Meter, Peak Flow, Spirometry), a Class II device regulated under 21 CFR 868.1860. Monaghan Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 1997
- Date Received
- October 15, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Meter, Peak Flow, Spirometry
- Device Class
- Class II
- Regulation Number
- 868.1860
- Review Panel
- AN
- Submission Type