510(k) K884542
K884542 is an FDA 510(k) premarket notification submitted by Commercial Products & Engineering Co. for the device "SIC 3999 FOLDING ADJUSTABLE HOSPITAL BED". The FDA issued a decision of Substantially Equivalent on November 21, 1988. The device falls under product code FNJ (Bed, Manual), a Class I device regulated under 21 CFR 880.5120. Commercial Products & Engineering Co. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 1988
- Date Received
- October 31, 1988
- 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