510(k) K934502
K934502 is an FDA 510(k) premarket notification submitted by Healthdyne, Inc. for the device "FLOW SPIROMETER". The FDA issued a decision of Substantially Equivalent on April 4, 1994. The device falls under product code BZH (Meter, Peak Flow, Spirometry), a Class II device regulated under 21 CFR 868.1860. Healthdyne, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 1994
- Date Received
- September 14, 1993
- 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