510(k) K812039
K812039 is an FDA 510(k) premarket notification submitted by Medix Medical Electronics (U.S.A.), Inc. for the device "SPIROMETER 210/211". The FDA issued a decision of Substantially Equivalent on September 25, 1981. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Medix Medical Electronics (U.S.A.), Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 1981
- Date Received
- July 21, 1981
- 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