510(k) K881689
K881689 is an FDA 510(k) premarket notification submitted by Lindley Resuscitator, Inc. for the device "LINDLEY II RESUSCITATOR". The FDA issued a decision of Substantially Equivalent on July 8, 1988. The device falls under product code BYT (Ventilator, External Body, Negative Pressure, Adult (Cuirass)), a Class II device regulated under 21 CFR 868.5935.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 8, 1988
- Date Received
- April 19, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, External Body, Negative Pressure, Adult (Cuirass)
- Device Class
- Class II
- Regulation Number
- 868.5935
- Review Panel
- AN
- Submission Type