510(k) K905520
K905520 is an FDA 510(k) premarket notification submitted by Synectics-Dantec for the device "MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION". The FDA issued a decision of Substantially Equivalent on April 26, 1991. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Synectics-Dantec has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 26, 1991
- Date Received
- December 7, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Breathing Frequency
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type