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FDA 510(k)

OPHTHASCAN B

K-Number: K844686 · 1985-09-13

ApplicantBiophysic Medical, Inc.
Decision Date1985-09-13
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPHTHASCAN B is the device name listed in this FDA 510(k) record. The listed applicant is Biophysic Medical, Inc.. It received FDA 510(k) clearance on 1985-09-13 under 510(k) number K844686. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTHASCAN B?

OPHTHASCAN B is a medical device that received FDA 510(k) clearance on 1985-09-13. The listed applicant is Biophysic Medical, Inc.. The 510(k) number is K844686.

When did OPHTHASCAN B receive FDA 510(k) clearance?

OPHTHASCAN B received FDA 510(k) clearance on 1985-09-13, under 510(k) number K844686.

Who is the listed applicant for OPHTHASCAN B?

The FDA 510(k) record lists Biophysic Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPHTHASCAN B?

The FDA product code for OPHTHASCAN B is IYO.

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Other records listing Biophysic Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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