510(k) K962942
K962942 is an FDA 510(k) premarket notification submitted by Hill-Rom, Inc. for the device "TOTALCARE". The FDA issued a decision of Substantially Equivalent on February 3, 1997. The device falls under product code FNL (Bed, Ac-Powered Adjustable Hospital), a Class II device regulated under 21 CFR 880.5100. Hill-Rom, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 1997
- Date Received
- July 29, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bed, Ac-Powered Adjustable Hospital
- Device Class
- Class II
- Regulation Number
- 880.5100
- Review Panel
- HO
- Submission Type