510(k) K801935
K801935 is an FDA 510(k) premarket notification submitted by Volunteer Blind Industries, Inc. for the device "PAD, HOSPITAL STRETCHER". The FDA issued a decision of Substantially Equivalent on August 27, 1980. The device falls under product code FPO (Stretcher, Wheeled), a Class II device regulated under 21 CFR 880.6910. Volunteer Blind Industries, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 1980
- Date Received
- August 12, 1980
- 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