510(k) K944929
K944929 is an FDA 510(k) premarket notification submitted by Merivaara Instrumentarium Corp. for the device "OPTIMA DELIVERY BED (MODELS 33901, 33903, 33902, 33905)". The FDA issued a decision of Substantially Equivalent on November 22, 1994. The device falls under product code FNK (Bed, Hydraulic, Adjustable Hospital), a Class I device regulated under 21 CFR 880.5110. Merivaara Instrumentarium Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 1994
- Date Received
- October 6, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bed, Hydraulic, Adjustable Hospital
- Device Class
- Class I
- Regulation Number
- 880.5110
- Review Panel
- HO
- Submission Type