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FDA 510(k)

OPHTHASCAN MINI-B

K-Number: K884595 · 1989-01-03

ApplicantBiophysic Medical, Inc.
Decision Date1989-01-03
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPHTHASCAN MINI-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 1989-01-03 under 510(k) number K884595. 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 MINI-B?

OPHTHASCAN MINI-B is a medical device that received FDA 510(k) clearance on 1989-01-03. The listed applicant is Biophysic Medical, Inc.. The 510(k) number is K884595.

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

OPHTHASCAN MINI-B received FDA 510(k) clearance on 1989-01-03, under 510(k) number K884595.

Who is the listed applicant for OPHTHASCAN MINI-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 MINI-B?

The FDA product code for OPHTHASCAN MINI-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.

K953399NEEDLE OR CUTTERK893035OPHTHASCAN 'S' MINI-AK890509INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEMK884456STERILE DISPOSABLE ENDOCULAR PROBEK883719INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEMK881494FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER

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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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