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FDA 510(k)

MIZUHO RADIOLUCENT HEAD FRAME

K-Number: K955012 · 1996-09-12

ApplicantMizuho America, Inc.
Decision Date1996-09-12
Product CodeHBL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MIZUHO RADIOLUCENT HEAD FRAME is the device name listed in this FDA 510(k) record. The listed applicant is Mizuho America, Inc.. It received FDA 510(k) clearance on 1996-09-12 under 510(k) number K955012. The device is classified under product code HBL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIZUHO RADIOLUCENT HEAD FRAME?

MIZUHO RADIOLUCENT HEAD FRAME is a medical device that received FDA 510(k) clearance on 1996-09-12. The listed applicant is Mizuho America, Inc.. The 510(k) number is K955012.

When did MIZUHO RADIOLUCENT HEAD FRAME receive FDA 510(k) clearance?

MIZUHO RADIOLUCENT HEAD FRAME received FDA 510(k) clearance on 1996-09-12, under 510(k) number K955012.

Who is the listed applicant for MIZUHO RADIOLUCENT HEAD FRAME?

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

What is the FDA product code for MIZUHO RADIOLUCENT HEAD FRAME?

The FDA product code for MIZUHO RADIOLUCENT HEAD FRAME is HBL.

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Other records listing Mizuho America, Inc. as applicant

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Related Devices (Code: HBL)

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Official Source

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

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