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FDA 510(k)

MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM

K-Number: K893911 · 1989-08-29

ApplicantMedical Equipment Development Co., Inc.
Decision Date1989-08-29
Product CodeHBL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Equipment Development Co., Inc.. It received FDA 510(k) clearance on 1989-08-29 under 510(k) number K893911. 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 MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM?

MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1989-08-29. The listed applicant is Medical Equipment Development Co., Inc.. The 510(k) number is K893911.

When did MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM receive FDA 510(k) clearance?

MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM received FDA 510(k) clearance on 1989-08-29, under 510(k) number K893911.

Who is the listed applicant for MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM?

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

What is the FDA product code for MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM?

The FDA product code for MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM is HBL.

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Other records listing Medical Equipment Development Co., Inc. as applicant

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Related Devices (Code: HBL)

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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