FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMEDA AMELETTE(R) NEONATAL INCUBATOR
K Number: K870223
·
Decision Jun 10, 1987
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
84
Applicant Total
85
Review Days
140
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Basic Information
- Device Name
- AMEDA AMELETTE(R) NEONATAL INCUBATOR
- K Number
- K870223
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5400
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Hollister, Inc.
- Date Received
- January 21, 1987
- Decision Date
- June 10, 1987
- 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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|---|---|---|---|
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| K050483 | EVADRI BLADDER CONTROL SYSTEMS | Apr 12, 2005 | Substantially Equivalent |
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| K013483 | INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT | Jan 14, 2002 | Substantially Equivalent |
| K013345 | INCARE INTERMITTENT CATHETER | Jan 7, 2002 | Substantially Equivalent |