510(k) K864203
K864203 is an FDA 510(k) premarket notification submitted by J. Nesbit Evans & Co. for the device "NESBIT EVANS NURSING HOME BED". The FDA issued a decision of Substantially Equivalent on November 7, 1986. The device falls under product code FNJ (Bed, Manual), a Class I device regulated under 21 CFR 880.5120.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 1986
- Date Received
- October 27, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bed, Manual
- Device Class
- Class I
- Regulation Number
- 880.5120
- Review Panel
- HO
- Submission Type