510(k) K923402
K923402 is an FDA 510(k) premarket notification submitted by Pro-Tech, Inc. for the device "CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR". The FDA issued a decision of Substantially Equivalent on Dec 30, 1992. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Pro-Tech, Inc. has 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 30, 1992
- Date Received
- Jul 10, 1992
- 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)