FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 215M PATIENT SIMULATOR
K Number: K897074
·
Decision May 17, 1990
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
6
Review Days
146
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Basic Information
- Device Name
- MODEL 215M PATIENT SIMULATOR
- K Number
- K897074
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Dynatech/Nevada, Inc.
- Date Received
- December 22, 1989
- Decision Date
- May 17, 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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Other Clearances by Dynatech/Nevada, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942546 | CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER | Jan 27, 1995 | Substantially Equivalent |
| K935817 | MEDSIM 300 PATIENT SIMULATOR | Jan 18, 1994 | Substantially Equivalent |
| K934254 | IMPULSE 3000 DEFIBRILLATOR ANALYZER | Nov 23, 1993 | Substantially Equivalent |
| K897029 | MODEL ECG100 SIMULATOR | Apr 26, 1990 | Substantially Equivalent |
| K897096 | MODEL 404A I.V. INFUSION PUMP ANALYZER | Mar 15, 1990 | Substantially Equivalent |