FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SPACE LABS MODEL 90560
K Number: K923788
·
Decision Dec 6, 1993
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
46
Review Days
496
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Basic Information
- Device Name
- SPACE LABS MODEL 90560
- K Number
- K923788
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spacelabs, Inc.
- Date Received
- July 28, 1992
- Decision Date
- December 6, 1993
- Product Code
- LOS
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LOS), ordered by most recent decision date.
Other Clearances by Spacelabs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954962 | SPACELABS MEDICAL MULTIGAS ANALYZER | May 31, 1996 | Substantially Equivalent |
| K951605 | SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM | Jul 14, 1995 | Substantially Equivalent |
| K950779 | HEART RATE VARIABILITY SOFTWARE OPTION | Apr 25, 1995 | Substantially Equivalent |
| K941165 | COMET CAPNOGRAPH MODULE | Oct 6, 1994 | 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 |
| K904318 | LOCAL REPORT GENERATOR | Dec 18, 1990 | Substantially Equivalent |