FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES
K Number: K853038
·
Decision Jan 7, 1986
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
17
Review Days
172
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Basic Information
- Device Name
- DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES
- K Number
- K853038
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Bio-Detek, Inc.
- Date Received
- July 19, 1985
- Decision Date
- January 7, 1986
- Product Code
- DRX
- 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | FDA class 2 | Cardiovascular |
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