FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INFANT EVALUATION CARRIER
K Number: K831731
·
Decision Jul 18, 1983
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
38
Applicant Total
21
Review Days
48
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Basic Information
- Device Name
- INFANT EVALUATION CARRIER
- K Number
- K831731
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6900
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- E.M. Adams
- Date Received
- May 31, 1983
- Decision Date
- July 18, 1983
- Product Code
- FPP
- 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 |
|---|---|---|---|
| FPP | Stretcher, Hand-Carried | FDA class 1 | General Hospital |
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Other Clearances by E.M. Adams
| K Number | Device Name | ||
|---|---|---|---|
| K905173 | SPLASH GUARD | Apr 25, 1991 | Substantially Equivalent |
| K910468 | STERILE DISPOSABLE DRAPE(S) | Mar 21, 1991 | Substantially Equivalent |
| K873978 | DISPOSABLE BIPOLAR FORCEPS | Nov 23, 1987 | Substantially Equivalent |
| K850063 | INSTRUMENT POCKET | Feb 21, 1985 | Substantially Equivalent |
| K843724 | I.V. START KIT & OBSTETRICAL KIT | Jan 10, 1985 | Substantially Equivalent |
| K843783 | WET PACK | Dec 19, 1984 | Substantially Equivalent |
| K843782 | DRY TRAY | Dec 13, 1984 | Substantially Equivalent |
| K843723 | STERILE INSTRUMENT TRAYS-VARIOUS | Oct 23, 1984 | Substantially Equivalent |
| K843115 | STERILE SOLUTION BOWL | Sep 7, 1984 | Substantially Equivalent |
| K843116 | DISPOSABLE SKIN MARKING PEN | Aug 17, 1984 | Substantially Equivalent |