OPTIMA DELIVERY BED (MODELS 33901, 33903, 33902, 33905)
FDA 510(k) clearance K944929 · decided 1994-11-22
Clearance details
- K-number
- K944929
- Device name
- OPTIMA DELIVERY BED (MODELS 33901, 33903, 33902, 33905)
- Applicant
- Merivaara Instrumentarium Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-10-06
- Decision date
- 1994-11-22
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- FNK
- Device class
- 1
- Regulation number
- 880.5110
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lahti, FI
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.