FDA 510(k)

WBA - I.R.I.S.

K-Number: K842895 · 1984-08-27

Decision Date1984-08-27

Product CodeJAM

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

WBA - I.R.I.S. is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Gammasonics, Inc.. It received FDA 510(k) clearance on 1984-08-27 under 510(k) number K842895. The device is classified under product code JAM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WBA - I.R.I.S.?

WBA - I.R.I.S. is a medical device that received FDA 510(k) clearance on 1984-08-27. The listed applicant is Siemens Gammasonics, Inc.. The 510(k) number is K842895.

When did WBA - I.R.I.S. receive FDA 510(k) clearance?

WBA - I.R.I.S. received FDA 510(k) clearance on 1984-08-27, under 510(k) number K842895.

Who is the listed applicant for WBA - I.R.I.S.?

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

What is the FDA product code for WBA - I.R.I.S.?

The FDA product code for WBA - I.R.I.S. is JAM.

Other records listing Siemens Gammasonics, Inc. 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.

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Related Devices (Code: JAM)

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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.