FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TR-3 TRANSMITTER
K Number: K760857
·
Decision Jan 28, 1977
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
296
Applicant Total
38
Review Days
105
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Basic Information
- Device Name
- TR-3 TRANSMITTER
- K Number
- K760857
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2920
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Burdick Corp.
- Date Received
- October 15, 1976
- Decision Date
- January 28, 1977
- 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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| K883440 | E550 ELECTROCARDIOGRAPH | Jan 17, 1989 | Substantially Equivalent |
| K873774 | M300 MONITOR/CONTROLLER T500 TREADMILL | Nov 6, 1987 | Substantially Equivalent |
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