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FDA 510(k)

PENASE

K-Number: K833888 · 1984-01-03

ApplicantOxoid U.S.A., Inc.
Decision Date1984-01-03
Product CodeMDB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PENASE is the device name listed in this FDA 510(k) record. The listed applicant is Oxoid U.S.A., Inc.. It received FDA 510(k) clearance on 1984-01-03 under 510(k) number K833888. The device is classified under product code MDB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENASE?

PENASE is a medical device that received FDA 510(k) clearance on 1984-01-03. The listed applicant is Oxoid U.S.A., Inc.. The 510(k) number is K833888.

When did PENASE receive FDA 510(k) clearance?

PENASE received FDA 510(k) clearance on 1984-01-03, under 510(k) number K833888.

Who is the listed applicant for PENASE?

The FDA 510(k) record lists Oxoid U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PENASE?

The FDA product code for PENASE is MDB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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