FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON
K Number: K792283
·
Decision Nov 21, 1979
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
23
Applicant Total
2
Review Days
8
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Basic Information
- Device Name
- ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON
- K Number
- K792283
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2050
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Arzbaecher & Co.
- Date Received
- November 13, 1979
- Decision Date
- November 21, 1979
- Product Code
- DRR
- 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 |
|---|---|---|---|
| DRR | Amplifier And Signal Conditioner, Biopotential | FDA class 2 | Cardiovascular |
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Other Clearances by Arzbaecher & Co.
| K Number | Device Name | ||
|---|---|---|---|
| K800201 | ESOPHAGEAL PILL-ELECTRODE | Feb 26, 1980 | Substantially Equivalent |