FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR
K Number: K900735
·
Decision May 2, 1990
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
84
Applicant Total
9
Review Days
75
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Basic Information
- Device Name
- MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR
- K Number
- K900735
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5400
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Preemicare Corp.
- Date Received
- February 16, 1990
- Decision Date
- May 2, 1990
- 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 Preemicare Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K911450 | INFANT VENTILATOR | Jun 18, 1991 | Substantially Equivalent |
| K896375 | PREEMICARE NEBUTECH NEBULIZER SYSTEM | Oct 29, 1990 | Substantially Equivalent |
| K893622 | PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL. | Jan 3, 1990 | Substantially Equivalent |
| K893624 | PREEMICARE MODEL 2500 TRANSPORT WARMER | Sep 27, 1989 | Substantially Equivalent |
| K891674 | NEONATAL ENVIRONMENTAL MONITOR, MODEL 275 | Aug 31, 1989 | Substantially Equivalent |
| K885350 | PREEMICARE SERIES 2000 INFANT WARMER | Aug 7, 1989 | Substantially Equivalent |
| K884133 | PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP | Mar 8, 1989 | Substantially Equivalent |
| K881476 | PREEMICARE MODEL D1-X1, SERIES 3000 | Dec 8, 1988 | Substantially Equivalent |