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FDA 510(k)

IMAGING JET SYSTEM

K-Number: K970782 · 1997-11-13

ApplicantGeneral Robotic Devices, Inc.
Decision Date1997-11-13
Product CodeJAB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGING JET SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is General Robotic Devices, Inc.. It received FDA 510(k) clearance on 1997-11-13 under 510(k) number K970782. The device is classified under product code JAB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGING JET SYSTEM?

IMAGING JET SYSTEM is a medical device that received FDA 510(k) clearance on 1997-11-13. The listed applicant is General Robotic Devices, Inc.. The 510(k) number is K970782.

When did IMAGING JET SYSTEM receive FDA 510(k) clearance?

IMAGING JET SYSTEM received FDA 510(k) clearance on 1997-11-13, under 510(k) number K970782.

Who is the listed applicant for IMAGING JET SYSTEM?

The FDA 510(k) record lists General Robotic Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMAGING JET SYSTEM?

The FDA product code for IMAGING JET SYSTEM is JAB.

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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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