FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIEMENS CLINICAL WORK STATION
K Number: K935043
·
Decision Apr 7, 1995
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
15
Review Days
533
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Basic Information
- Device Name
- SIEMENS CLINICAL WORK STATION
- K Number
- K935043
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Medical Electronics
- Date Received
- October 21, 1993
- Decision Date
- April 7, 1995
- Product Code
- DQK
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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Other Clearances by Siemens Medical Electronics
| K Number | Device Name | ||
|---|---|---|---|
| K921930 | SIEMENS SIRECUST 700 BEDSIDES/ACCESSORIES, MODIFI | May 7, 1993 | Substantially Equivalent |
| K920445 | SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES | Mar 2, 1993 | Substantially Equivalent |
| K914765 | SIEMENS NP NONINVASIVE BLOOD PRESS MEASUREMENT SYS | Nov 6, 1992 | Substantially Equivalent |
| K912070 | SIEMENS RADIOTOM 904 & 904E ELECTROSURGERY UNIT | Apr 23, 1992 | Substantially Equivalent |
| K913489 | SIEMENS MICRO2 PULSE OXIMETER | Oct 30, 1991 | Substantially Equivalent |
| K905775 | SIEMENS ETCO2 CARTRIDGE | Mar 11, 1991 | Substantially Equivalent |
| K900319 | SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEM | Jun 28, 1990 | Substantially Equivalent |
| K901771 | SIEMENS SIRECUST 732, PATIENT MONITOR | May 30, 1990 | Substantially Equivalent |
| K894460 | SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIA | Oct 2, 1989 | Substantially Equivalent |
| K891481 | SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE | Sep 29, 1989 | Substantially Equivalent |