510(k) K950397
K950397 is an FDA 510(k) premarket notification submitted by Turnkey Intergration USA, Inc. for the device "SYSTEM 22 VALVE". The FDA issued a decision of Substantially Equivalent on April 14, 1995. The device falls under product code BYE (Attachment, Breathing, Positive End Expiratory Pressure), a Class II device regulated under 21 CFR 868.5965. Turnkey Intergration USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 1995
- Date Received
- February 1, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Attachment, Breathing, Positive End Expiratory Pressure
- Device Class
- Class II
- Regulation Number
- 868.5965
- Review Panel
- AN
- Submission Type