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FDA 510(k)

CONVERTER SYSTEM

K-Number: K894248 · 1990-02-27

ApplicantMira, Inc.
Decision Date1990-02-27
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CONVERTER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mira, Inc.. It received FDA 510(k) clearance on 1990-02-27 under 510(k) number K894248. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONVERTER SYSTEM?

CONVERTER SYSTEM is a medical device that received FDA 510(k) clearance on 1990-02-27. The listed applicant is Mira, Inc.. The 510(k) number is K894248.

When did CONVERTER SYSTEM receive FDA 510(k) clearance?

CONVERTER SYSTEM received FDA 510(k) clearance on 1990-02-27, under 510(k) number K894248.

Who is the listed applicant for CONVERTER SYSTEM?

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

What is the FDA product code for CONVERTER SYSTEM?

The FDA product code for CONVERTER SYSTEM is HQE.

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Other records listing Mira, Inc. as applicant

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K951728SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPEK950806SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTSK941495RETURN PATH DIATHERMY HANDLEK933527MODIFICATION OF ANTERIOR SEGMENT ELECTRODESK923629OPHTHALMIC TRICHIASIS PROBEK891601POWER OPERATED AND CONTROLLED VITREOUS SCISSORS

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Related Devices (Code: HQE)

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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