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FDA 510(k)

DVS (OPTION 01)

K-Number: K883101 · 1988-10-07

Decision Date1988-10-07
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DVS (OPTION 01) is the device name listed in this FDA 510(k) record. The listed applicant is O.M.I. Oncology Microsystems, Inc.. It received FDA 510(k) clearance on 1988-10-07 under 510(k) number K883101. 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 DVS (OPTION 01)?

DVS (OPTION 01) is a medical device that received FDA 510(k) clearance on 1988-10-07. The listed applicant is O.M.I. Oncology Microsystems, Inc.. The 510(k) number is K883101.

When did DVS (OPTION 01) receive FDA 510(k) clearance?

DVS (OPTION 01) received FDA 510(k) clearance on 1988-10-07, under 510(k) number K883101.

Who is the listed applicant for DVS (OPTION 01)?

The FDA 510(k) record lists O.M.I. Oncology Microsystems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DVS (OPTION 01)?

The FDA product code for DVS (OPTION 01) is IYE.

Related Clinical Trials

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.

Other records listing O.M.I. Oncology Microsystems, 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.

Related Devices (Code: IYE)

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.

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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