FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE
K Number: K924324
·
Decision Nov 12, 1993
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
84
Applicant Total
2
Review Days
442
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Basic Information
- Device Name
- K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE
- K Number
- K924324
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5400
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- K-1 Medical Products, Inc.
- Date Received
- August 27, 1992
- Decision Date
- November 12, 1993
- Product Code
- FMZ
- 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 |
|---|---|---|---|
| FMZ | Incubator, Neonatal | FDA class 2 | General Hospital |
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Other Clearances by K-1 Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K895550 | K-1 INFANT TRANSPORT SYSTEM | Dec 7, 1989 | Substantially Equivalent |