FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERSALET 7700 CARE CENTER
K Number: K053399
·
Decision Aug 4, 2006
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
84
Applicant Total
2
Review Days
241
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Basic Information
- Device Name
- VERSALET 7700 CARE CENTER
- K Number
- K053399
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5400
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Draeger Medical Infant Care, Inc.
- Date Received
- December 6, 2005
- Decision Date
- August 4, 2006
- 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 Draeger Medical Infant Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042522 | JAUNDICE METER, MODEL JM 103 | Jul 6, 2005 | Substantially Equivalent |