7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)
FDA 510(k) clearance K902728 · decided 1991-02-13
Clearance details
- K-number
- K902728
- Device name
- 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)
- Applicant
- Ausonics Pty , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1990-06-21
- Decision date
- 1991-02-13
- Days to decision
- 237 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Suffield, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.