510(k) K780371
K780371 is an FDA 510(k) premarket notification submitted by Medical Specialty Products, Inc. for the device "TILT TYPE AC POWERED HOSPITAL BED". The FDA issued a decision of Substantially Equivalent on April 10, 1978. The device falls under product code FNL (Bed, Ac-Powered Adjustable Hospital), a Class II device regulated under 21 CFR 880.5100. Medical Specialty Products, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 1978
- Date Received
- March 7, 1978
- 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