TR-3 TRANSMITTER
FDA 510(k) clearance K760857 · decided 1977-01-28
Clearance details
- K-number
- K760857
- Device name
- TR-3 TRANSMITTER
- Applicant
- Burdick Corp.
- Decision
- Substantially Equivalent
- Date received
- 1976-10-15
- Decision date
- 1977-01-28
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- DXH
- Device class
- 2
- Regulation number
- 870.2920
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.