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FDA 510(k), K896017, THE OPHTHIMUS SYSTEM
FDA 510(k), K896017, THE OPHTHIMUS SYSTEM
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510(K) Number: K896017
Device Name: THE OPHTHIMUS SYSTEM
Manufacturer: HIGHTECH VISION
Device Classification Name: computer, diagnostic, programmable
Regulation Number: 870.1425
Classification Product Code: DQK
Date Received: 10/16/1989
Decision Date: 10/02/1990
Regulation Medical Specialty: Cardiovascular
Device Name: THE OPHTHIMUS SYSTEM
Manufacturer: HIGHTECH VISION
Device Classification Name: computer, diagnostic, programmable
Regulation Number: 870.1425
Classification Product Code: DQK
Date Received: 10/16/1989
Decision Date: 10/02/1990
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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