510(k) K884759
K884759 is an FDA 510(k) premarket notification submitted by Linido, Inc. for the device "SHOWER STRETCHER W/WHEELS". The FDA issued a decision of Substantially Equivalent on June 15, 1989. The device falls under product code FPO (Stretcher, Wheeled), a Class II device regulated under 21 CFR 880.6910. Linido, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 15, 1989
- Date Received
- November 14, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stretcher, Wheeled
- Device Class
- Class II
- Regulation Number
- 880.6910
- Review Panel
- HO
- Submission Type