VOROSCOPE(TM)
FDA 510(k) clearance K871735 · decided 1987-06-03
Clearance details
- K-number
- K871735
- Device name
- VOROSCOPE(TM)
- Applicant
- Australian Biomedical Corporation , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1987-05-05
- Decision date
- 1987-06-03
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- HLJ
- Device class
- 2
- Regulation number
- 886.1570
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Australia, AU
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.