510(k) K965042
K965042 is an FDA 510(k) premarket notification submitted by Micro Direct, Inc. for the device "MICRODL DIARYCARD SPIROMETER". The FDA issued a decision of Substantially Equivalent on June 17, 1997. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Micro Direct, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 1997
- Date Received
- December 17, 1996
- 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