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FDA 510(k)

EXTRA LARGE QUAD FLEX SPINE COIL

K-Number: K940602 · 1994-05-23

ApplicantHitachi Medical Systems America, Inc.
Decision Date1994-05-23
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXTRA LARGE QUAD FLEX SPINE COIL is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 1994-05-23 under 510(k) number K940602. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTRA LARGE QUAD FLEX SPINE COIL?

EXTRA LARGE QUAD FLEX SPINE COIL is a medical device that received FDA 510(k) clearance on 1994-05-23. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K940602.

When did EXTRA LARGE QUAD FLEX SPINE COIL receive FDA 510(k) clearance?

EXTRA LARGE QUAD FLEX SPINE COIL received FDA 510(k) clearance on 1994-05-23, under 510(k) number K940602.

Who is the listed applicant for EXTRA LARGE QUAD FLEX SPINE COIL?

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

What is the FDA product code for EXTRA LARGE QUAD FLEX SPINE COIL?

The FDA product code for EXTRA LARGE QUAD FLEX SPINE COIL is LNH.

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Other records listing Hitachi Medical Systems America, 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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