FDA 510(k)

VFSS IMAGER, MODEL SIS-300

K-Number: K000987 · 2000-06-01

Decision Date2000-06-01

Product CodeJAA

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

VFSS IMAGER, MODEL SIS-300 is the device name listed in this FDA 510(k) record. The listed applicant is Lifecare Imaging Intl., Ltd.. It received FDA 510(k) clearance on 2000-06-01 under 510(k) number K000987. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VFSS IMAGER, MODEL SIS-300?

VFSS IMAGER, MODEL SIS-300 is a medical device that received FDA 510(k) clearance on 2000-06-01. The listed applicant is Lifecare Imaging Intl., Ltd.. The 510(k) number is K000987.

When did VFSS IMAGER, MODEL SIS-300 receive FDA 510(k) clearance?

VFSS IMAGER, MODEL SIS-300 received FDA 510(k) clearance on 2000-06-01, under 510(k) number K000987.

Who is the listed applicant for VFSS IMAGER, MODEL SIS-300?

The FDA 510(k) record lists Lifecare Imaging Intl., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VFSS IMAGER, MODEL SIS-300?

The FDA product code for VFSS IMAGER, MODEL SIS-300 is JAA.

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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.