FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEAD & FOOT END DROP PEDI-CRIB
K Number: K925817
·
Decision Apr 20, 1993
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
26
Applicant Total
5
Review Days
154
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Basic Information
- Device Name
- HEAD & FOOT END DROP PEDI-CRIB
- K Number
- K925817
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5140
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pedicraft, Inc.
- Date Received
- November 17, 1992
- Decision Date
- April 20, 1993
- Product Code
- FMS
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMS | Bed, Pediatric Open Hospital | FDA class 2 | General Hospital |
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Other Clearances by Pedicraft, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K925949 | PEDICRAGT BASSINET | Apr 20, 1993 | Substantially Equivalent |
| K905630 | INFANT REFLUX SLING | Mar 13, 1991 | Substantially Equivalent |
| K905629 | PEDICRAFT INFANT REFLUX WEDGE | Mar 13, 1991 | Substantially Equivalent |
| K821773 | PEDICRAFT BED, MODEL B2944 | Jun 23, 1982 | Substantially Equivalent |