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FDA 510(k)

ACCESSORIES TO THE STEREOTACTIC BODY FRAM

K-Number: K970291 · 1997-04-24

ApplicantElekta Instrument AB
Decision Date1997-04-24
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACCESSORIES TO THE STEREOTACTIC BODY FRAM is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Instrument AB. It received FDA 510(k) clearance on 1997-04-24 under 510(k) number K970291. 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 ACCESSORIES TO THE STEREOTACTIC BODY FRAM?

ACCESSORIES TO THE STEREOTACTIC BODY FRAM is a medical device that received FDA 510(k) clearance on 1997-04-24. The listed applicant is Elekta Instrument AB. The 510(k) number is K970291.

When did ACCESSORIES TO THE STEREOTACTIC BODY FRAM receive FDA 510(k) clearance?

ACCESSORIES TO THE STEREOTACTIC BODY FRAM received FDA 510(k) clearance on 1997-04-24, under 510(k) number K970291.

Who is the listed applicant for ACCESSORIES TO THE STEREOTACTIC BODY FRAM?

The FDA 510(k) record lists Elekta Instrument AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCESSORIES TO THE STEREOTACTIC BODY FRAM?

The FDA product code for ACCESSORIES TO THE STEREOTACTIC BODY FRAM is IYE.

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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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