FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO
K Number: K851517
·
Decision Oct 2, 1985
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
13
Review Days
170
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Basic Information
- Device Name
- CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO
- K Number
- K851517
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Circadian, Inc.
- Date Received
- April 15, 1985
- Decision Date
- October 2, 1985
- 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 Circadian, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K921878 | SCANMATE III | Sep 11, 1992 | Substantially Equivalent |
| K894956 | CIRCAMED HOLTER VERSION 4 | Feb 5, 1990 | Substantially Equivalent |
| K874641 | CIRCADIAN STRESS TEST II | Apr 1, 1988 | Substantially Equivalent |
| K874155 | CIRCAMED MONITOR REMOTE START CONDUCTANCE METER | Nov 23, 1987 | Substantially Equivalent |
| K871251 | CIRCAMED FULL DISCLOSURE SYSTEM | May 22, 1987 | Substantially Equivalent |
| K860973 | CIRCADIAN STRESS TEST SYSTEM | Aug 25, 1986 | Substantially Equivalent |
| K851643 | REMOTE CONTROL MODULE | Sep 9, 1985 | Substantially Equivalent |
| K840741 | PULMONARY FUNCTION TESTING STS | Mar 5, 1984 | Substantially Equivalent |
| K833619 | CONDUCTANCE METER | Jan 27, 1984 | Substantially Equivalent |
| K830830 | CIRCA MED TWO-CHANNEL | Jun 18, 1983 | Substantially Equivalent |