510(k) K022124
K022124 is an FDA 510(k) premarket notification submitted by Galemed Corp. for the device "GALEMED PEAK FLOW METER, MODELS 3751/3752". The FDA issued a decision of Substantially Equivalent on April 3, 2003. The device falls under product code BZH (Meter, Peak Flow, Spirometry), a Class II device regulated under 21 CFR 868.1860. Galemed Corp. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 2003
- Date Received
- July 1, 2002
- 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