FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MTC XI UL
K Number: K871178
·
Decision Oct 9, 1987
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
91
Applicant Total
2
Review Days
199
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Basic Information
- Device Name
- MTC XI UL
- K Number
- K871178
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5130
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Aragona Medical, Inc.
- Date Received
- March 24, 1987
- Decision Date
- October 9, 1987
- Product Code
- FMT
- 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 |
|---|---|---|---|
| FMT | Warmer, Infant Radiant | FDA class 2 | General Hospital |
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Other Clearances by Aragona Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K871177 | NTH 101 UL | Oct 9, 1987 | Substantially Equivalent |