FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 90421 FLEXPORT INTERFACE
K Number: K903702
·
Decision Oct 19, 1990
Classifications
1
FEI Numbers
403
Registration Numbers
403
Same Product Code
711
Applicant Total
46
Review Days
80
Basic Information
- Device Name
- MODEL 90421 FLEXPORT INTERFACE
- K Number
- K903702
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- SPACELABS, INC.
- Date Received
- July 31, 1990
- Decision Date
- October 19, 1990
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
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| K Number | Device Name | ||
|---|---|---|---|
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| K950779 | HEART RATE VARIABILITY SOFTWARE OPTION | Apr 25, 1995 | Substantially Equivalent |
| K941165 | COMET CAPNOGRAPH MODULE | Oct 6, 1994 | Substantially Equivalent |
| K923788 | SPACE LABS MODEL 90560 | Dec 6, 1993 | Substantially Equivalent |
| K912742 | ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE | Apr 20, 1992 | Substantially Equivalent |
| K913038 | SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION | Oct 4, 1991 | Substantially Equivalent |
| K905065 | DEFIBRILLATOR LEAD ADAPTER | Apr 12, 1991 | Substantially Equivalent |
| K910029 | PATIENT CARE MANAGEMENT SYSTEM MODIFICATION | Jan 31, 1991 | Substantially Equivalent |
| K896903 | FIRST MEDIC MODEL 510 | Dec 27, 1990 | Substantially Equivalent |