APERTURE
FDA 510(k) clearance K895084 · decided 1989-10-27
Clearance details
- K-number
- K895084
- Device name
- APERTURE
- Applicant
- Custom Medical Products, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1989-08-14
- Decision date
- 1989-10-27
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- IZS
- Device class
- 2
- Regulation number
- 892.1610
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Deer Park, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.