FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE HOLTER REPORTER (TM)
K Number: K860249
·
Decision Mar 11, 1986
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
4
Review Days
46
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Basic Information
- Device Name
- THE HOLTER REPORTER (TM)
- K Number
- K860249
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Applied Cardiac Systems
- Date Received
- January 24, 1986
- Decision Date
- March 11, 1986
- Product Code
- DPS
- 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 |
|---|---|---|---|
| DPS | Electrocardiograph | FDA class 2 | Cardiovascular |
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