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FDA 510(k)

COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED

K-Number: K921740 · 1993-04-07

ApplicantMedical Instrumentation & Diagnostics Corp.(Midco)
Decision Date1993-04-07
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Medical Instrumentation & Diagnostics Corp.(Midco). It received FDA 510(k) clearance on 1993-04-07 under 510(k) number K921740. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED?

COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED is a medical device that received FDA 510(k) clearance on 1993-04-07. The listed applicant is Medical Instrumentation & Diagnostics Corp.(Midco). The 510(k) number is K921740.

When did COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED receive FDA 510(k) clearance?

COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED received FDA 510(k) clearance on 1993-04-07, under 510(k) number K921740.

Who is the listed applicant for COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED?

The FDA 510(k) record lists Medical Instrumentation & Diagnostics Corp.(Midco) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED?

The FDA product code for COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED is IYE.

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Other records listing Medical Instrumentation & Diagnostics Corp.(Midco) 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.

K991336BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPYK961484CASS SYSTEM (MODIFICATION)K911750COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIEDK902488MODIFIED CASS SYSTEMK894263CASS SYSTEM

Related Devices (Code: IYE)

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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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