510(k) K912352
K912352 is an FDA 510(k) premarket notification submitted by Peace Medical, Inc. for the device "PEACE MODEL 100 CUFF MONITOR". The FDA issued a decision of Substantially Equivalent on August 2, 1991. The device falls under product code BSK (Cuff, Tracheal Tube, Inflatable), a Class II device regulated under 21 CFR 868.5750. Peace Medical, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 1991
- Date Received
- May 28, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cuff, Tracheal Tube, Inflatable
- Device Class
- Class II
- Regulation Number
- 868.5750
- Review Panel
- AN
- Submission Type