510(k) K843681
K843681 is an FDA 510(k) premarket notification submitted by Tri-Med, Inc. for the device "RESPIRATION & HEART RATE MONITOR 530". The FDA issued a decision of Substantially Equivalent on December 4, 1984. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Tri-Med, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 1984
- Date Received
- September 18, 1984
- 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