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FDA 510(k)

MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME

K-Number: K874298 · 1988-02-04

ApplicantEngineered Orthopedic Technologies, Inc.
Decision Date1988-02-04
Product CodeHBL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME is the device name listed in this FDA 510(k) record. The listed applicant is Engineered Orthopedic Technologies, Inc.. It received FDA 510(k) clearance on 1988-02-04 under 510(k) number K874298. 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 MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME?

MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME is a medical device that received FDA 510(k) clearance on 1988-02-04. The listed applicant is Engineered Orthopedic Technologies, Inc.. The 510(k) number is K874298.

When did MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME receive FDA 510(k) clearance?

MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME received FDA 510(k) clearance on 1988-02-04, under 510(k) number K874298.

Who is the listed applicant for MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME?

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

What is the FDA product code for MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME?

The FDA product code for MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME is HBL.

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Other records listing Engineered Orthopedic Technologies, 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.

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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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