510(k) K864261
K864261 is an FDA 510(k) premarket notification submitted by Bio-Dyne, Inc. for the device "MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR". The FDA issued a decision of Substantially Equivalent on Mar 27, 1987. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Bio-Dyne, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 27, 1987
- Date Received
- Oct 29, 1986
- 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
- 510(k)