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FDA 510(k)

STEREOTACTIC BODY FRAME

K-Number: K960338 · 1996-04-23

ApplicantElekta Instrument AB
Decision Date1996-04-23
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STEREOTACTIC BODY FRAME 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 1996-04-23 under 510(k) number K960338. 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 STEREOTACTIC BODY FRAME?

STEREOTACTIC BODY FRAME is a medical device that received FDA 510(k) clearance on 1996-04-23. The listed applicant is Elekta Instrument AB. The 510(k) number is K960338.

When did STEREOTACTIC BODY FRAME receive FDA 510(k) clearance?

STEREOTACTIC BODY FRAME received FDA 510(k) clearance on 1996-04-23, under 510(k) number K960338.

Who is the listed applicant for STEREOTACTIC BODY FRAME?

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 STEREOTACTIC BODY FRAME?

The FDA product code for STEREOTACTIC BODY FRAME 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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