HEMISPHERE MULTIPLANE ENDORECTAL PROBE
FDA 510(k) clearance K911043 · decided 1991-10-09
Clearance details
- K-number
- K911043
- Device name
- HEMISPHERE MULTIPLANE ENDORECTAL PROBE
- Applicant
- Pie Medical Equipment B.V.
- Decision
- Substantially Equivalent
- Date received
- 1991-03-08
- Decision date
- 1991-10-09
- Days to decision
- 215 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Maastricht, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.