510(k) K854822
K854822 is an FDA 510(k) premarket notification submitted by Life Design Systems, Inc. for the device "LDS PEEP VALVE". The FDA issued a decision of Substantially Equivalent on February 24, 1986. The device falls under product code BYE (Attachment, Breathing, Positive End Expiratory Pressure), a Class II device regulated under 21 CFR 868.5965. Life Design Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 1986
- Date Received
- December 3, 1985
- 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