FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEONATAL ENVIRONMENTAL MONITOR, MODEL 275
K Number: K891674
·
Decision Aug 31, 1989
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
120
Applicant Total
9
Review Days
163
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Basic Information
- Device Name
- NEONATAL ENVIRONMENTAL MONITOR, MODEL 275
- K Number
- K891674
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1720
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Preemicare Corp.
- Date Received
- March 21, 1989
- Decision Date
- August 31, 1989
- Product Code
- CCL
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | FDA class 2 | Anesthesiology |
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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 |
| K900735 | MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR | May 2, 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 |
| 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 |