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FDA 510(k)

MINNESOTA SCIENTIFIC, INC. OMNI-BEAM

K-Number: K853948 · 1985-10-16

ApplicantMinnesota Scientific, Inc.
Decision Date1985-10-16
Product CodeHBI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MINNESOTA SCIENTIFIC, INC. OMNI-BEAM is the device name listed in this FDA 510(k) record. The listed applicant is Minnesota Scientific, Inc.. It received FDA 510(k) clearance on 1985-10-16 under 510(k) number K853948. The device is classified under product code HBI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINNESOTA SCIENTIFIC, INC. OMNI-BEAM?

MINNESOTA SCIENTIFIC, INC. OMNI-BEAM is a medical device that received FDA 510(k) clearance on 1985-10-16. The listed applicant is Minnesota Scientific, Inc.. The 510(k) number is K853948.

When did MINNESOTA SCIENTIFIC, INC. OMNI-BEAM receive FDA 510(k) clearance?

MINNESOTA SCIENTIFIC, INC. OMNI-BEAM received FDA 510(k) clearance on 1985-10-16, under 510(k) number K853948.

Who is the listed applicant for MINNESOTA SCIENTIFIC, INC. OMNI-BEAM?

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

What is the FDA product code for MINNESOTA SCIENTIFIC, INC. OMNI-BEAM?

The FDA product code for MINNESOTA SCIENTIFIC, INC. OMNI-BEAM is HBI.

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Other records listing Minnesota Scientific, Inc. as applicant

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Official Source

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