FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LABOR-DELIVERY STRETCH/BED
K Number: K861030
·
Decision Apr 23, 1986
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
25
Applicant Total
8
Review Days
36
Basic Information
- Device Name
- LABOR-DELIVERY STRETCH/BED
- K Number
- K861030
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4900
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- ADEL MEDICAL LTD.
- Date Received
- March 18, 1986
- Decision Date
- April 23, 1986
- 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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GARDOSI BIRTHING CUSHION
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Other Clearances by ADEL MEDICAL LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K890476 | ADEL - MODEL 986 INFANT WARMER | Jun 16, 1989 | Substantially Equivalent |
| K874610 | ADEL MODEL 2100 BIRTHING BED | Jan 21, 1988 | Substantially Equivalent |
| K871475 | SOLOLIFT - PATIENT TRANSFER STRETCHER | May 11, 1987 | Substantially Equivalent |
| K860020 | MINOR SURGERY LIGHT MODEL 2112 | Jan 24, 1986 | Substantially Equivalent |
| K833321 | LABOR/DELIVERY/RECOVERY BED LDR-600 | Nov 14, 1983 | Substantially Equivalent |
| K810886 | ADEL MEDICAL BIRTHING BED, #LD-500 | Apr 23, 1981 | Substantially Equivalent |
| K801622 | ADEL MEDICAL BIRTHING BED, MOD. LD-400 | Aug 14, 1980 | Substantially Equivalent |