FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CENTRAL STATION MONITOR CSM-100
K Number: K831818
·
Decision Oct 31, 1983
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
69
Review Days
147
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Basic Information
- Device Name
- CENTRAL STATION MONITOR CSM-100
- K Number
- K831818
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Honeywell, Inc.
- Date Received
- June 6, 1983
- Decision Date
- October 31, 1983
- Product Code
- DRT
- 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
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