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FDA 510(k)

COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIED

K-Number: K911750 · 1991-10-15

ApplicantMedical Instrumentation & Diagnostics Corp.(Midco)
Decision Date1991-10-15
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COMPUTER ASSIST STEREOTACTIC SURG SYST, 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 1991-10-15 under 510(k) number K911750. 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 ASSIST STEREOTACTIC SURG SYST, MODIFIED?

COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIED is a medical device that received FDA 510(k) clearance on 1991-10-15. The listed applicant is Medical Instrumentation & Diagnostics Corp.(Midco). The 510(k) number is K911750.

When did COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIED receive FDA 510(k) clearance?

COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIED received FDA 510(k) clearance on 1991-10-15, under 510(k) number K911750.

Who is the listed applicant for COMPUTER ASSIST STEREOTACTIC SURG SYST, 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 ASSIST STEREOTACTIC SURG SYST, MODIFIED?

The FDA product code for COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIED is IYE.

Related Clinical Trials

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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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)K921740COMPUTER ASSISTED STEREOTACTIC SURGERY -- 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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