FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BD6000 THE OPTIMA & BD5000 BIRTHING BED
K Number: K914544
·
Decision Nov 24, 1993
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
25
Applicant Total
2
Review Days
776
Basic Information
- Device Name
- BD6000 THE OPTIMA & BD5000 BIRTHING BED
- K Number
- K914544
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4900
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- LIC CARE, INC.
- Date Received
- October 10, 1991
- Decision Date
- November 24, 1993
- Product Code
- KNC
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KNC | Table, Obstetric (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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L720 EXAMINATION CHAIR
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OBSTETRICAL SAFETY SYSTEM
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Other Clearances by LIC CARE, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K914543 | ST5500 UNIVERSAL CARE STRETCHER | Jan 8, 1992 | Substantially Equivalent |