BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B
FDA 510(k) clearance K070195 · decided 2007-10-15
Clearance details
- K-number
- K070195
- Device name
- BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B
- Applicant
- Broadsound Corporation
- Decision
- Substantially Equivalent
- Date received
- 2007-01-22
- Decision date
- 2007-10-15
- Days to decision
- 266 days
- Clearance type
- Abbreviated
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Juipei City, Hsinchu, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.