FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRANSMITTER, TR-1 ECG
K Number: K782059
·
Decision Dec 21, 1978
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
292
Applicant Total
38
Review Days
14
Basic Information
- Device Name
- TRANSMITTER, TR-1 ECG
- K Number
- K782059
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2920
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- BURDICK CORP.
- Date Received
- December 7, 1978
- Decision Date
- December 21, 1978
- Product Code
- DXH
- 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 |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | FDA class 2 | Cardiovascular |
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