FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEM
K Number: K900319
·
Decision Jun 28, 1990
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
15
Review Days
156
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Basic Information
- Device Name
- SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEM
- K Number
- K900319
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Siemens Medical Electronics
- Date Received
- January 23, 1990
- Decision Date
- June 28, 1990
- Product Code
- DSI
- 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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| 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 |
| 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 |