BINOCULAR MAGNIFIER 2X
FDA 510(k) clearance K830774 · decided 1983-04-06
Clearance details
- K-number
- K830774
- Device name
- BINOCULAR MAGNIFIER 2X
- Applicant
- Almore Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-11
- Decision date
- 1983-04-06
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- HKC
- Device class
- 1
- Regulation number
- 886.5540
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.