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FDA 510(k)

INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM

K-Number: K890509 · 1989-03-24

ApplicantBiophysic Medical, Inc.
Decision Date1989-03-24
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM 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 1989-03-24 under 510(k) number K890509. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM?

INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1989-03-24. The listed applicant is Biophysic Medical, Inc.. The 510(k) number is K890509.

When did INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM receive FDA 510(k) clearance?

INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM received FDA 510(k) clearance on 1989-03-24, under 510(k) number K890509.

Who is the listed applicant for INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM?

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 INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM?

The FDA product code for INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM is HQF.

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Other records listing Biophysic Medical, Inc. as applicant

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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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