UST-5522-7.5 & UST-5522L-7.5 INTRAOPERATIVE TRANS.
FDA 510(k) clearance K925486 · decided 1993-02-12
Clearance details
- K-number
- K925486
- Device name
- UST-5522-7.5 & UST-5522L-7.5 INTRAOPERATIVE TRANS.
- Applicant
- Aloka Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1992-10-30
- Decision date
- 1993-02-12
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Wallingford, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.