FDA 510(k)
FDA class 1
Substantially Equivalent
🇫🇮 Finland
CARDIOCAP(TM) DR-104 REPORTER
K Number: K885058
·
Decision Jul 14, 1989
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
86
Applicant Total
55
Review Days
219
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Basic Information
- Device Name
- CARDIOCAP(TM) DR-104 REPORTER
- K Number
- K885058
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.2810
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Datex Division Instrumentarium Corp.
- Date Received
- December 7, 1988
- Decision Date
- July 14, 1989
- Product Code
- DSF
- 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 |
|---|---|---|---|
| DSF | Recorder, Paper Chart | FDA class 1 | Cardiovascular |
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