FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ESOPHAGEAL PILL ELECTRODE
K Number: K810895
·
Decision May 13, 1981
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
3
Review Days
40
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Basic Information
- Device Name
- ESOPHAGEAL PILL ELECTRODE
- K Number
- K810895
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Con Med Equipment, Inc.
- Date Received
- April 3, 1981
- Decision Date
- May 13, 1981
- 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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