FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFANT INCUBATOR, MODEL CHS-I1000
K Number: K040910
·
Decision Apr 21, 2004
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
84
Applicant Total
2
Review Days
13
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Basic Information
- Device Name
- INFANT INCUBATOR, MODEL CHS-I1000
- K Number
- K040910
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5400
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Choong Wae Medical Corp.
- Date Received
- April 8, 2004
- Decision Date
- April 21, 2004
- Product Code
- FMZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- Y
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 Choong Wae Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K083640 | DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D | Jun 29, 2009 | Substantially Equivalent |