510(k) K811865
K811865 is an FDA 510(k) premarket notification submitted by Vickers America Medical Corp. for the device "VMA PEDIATRIC APNEA MATTRESS". The FDA issued a decision of Substantially Equivalent on July 31, 1981. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Vickers America Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 1981
- Date Received
- July 1, 1981
- 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