510(k) K953363
K953363 is an FDA 510(k) premarket notification submitted by Edentec Corp. for the device "OXIFLOW DIGITAL RECORDER". The FDA issued a decision of ST on February 6, 1996. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Edentec Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- ST ()
- Decision Date
- February 6, 1996
- Date Received
- July 17, 1995
- 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