510(k) K841728
K841728 is an FDA 510(k) premarket notification submitted by Lehigh Consolidated Industries for the device "LCI MEDICAL INC AIR/PAL". The FDA issued a decision of Substantially Equivalent on Jun 5, 1984. The device falls under product code FRZ (Device, Patient Transfer, Powered), a Class II device regulated under 21 CFR 880.6775.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 5, 1984
- Date Received
- Apr 25, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Patient Transfer, Powered
- Device Class
- Class II
- Regulation Number
- 880.6775
- Review Panel
- HO
- Submission Type