510(k) K863134
K863134 is an FDA 510(k) premarket notification submitted by Biotrine Corp. for the device "MULTISPIRO SA/100". The FDA issued a decision of Substantially Equivalent on December 15, 1986. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Biotrine Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 1986
- Date Received
- August 15, 1986
- 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