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FDA 510(k)

OMNI-FAL I & II

K-Number: K833009 · 1984-01-13

ApplicantAmerican Monitor Corp.
Decision Date1984-01-13
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OMNI-FAL I & II is the device name listed in this FDA 510(k) record. The listed applicant is American Monitor Corp.. It received FDA 510(k) clearance on 1984-01-13 under 510(k) number K833009. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI-FAL I & II?

OMNI-FAL I & II is a medical device that received FDA 510(k) clearance on 1984-01-13. The listed applicant is American Monitor Corp.. The 510(k) number is K833009.

When did OMNI-FAL I & II receive FDA 510(k) clearance?

OMNI-FAL I & II received FDA 510(k) clearance on 1984-01-13, under 510(k) number K833009.

Who is the listed applicant for OMNI-FAL I & II?

The FDA 510(k) record lists American Monitor Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMNI-FAL I & II?

The FDA product code for OMNI-FAL I & II is JJY.

Other records listing American Monitor Corp. 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.

K896000ASPARTATE AMINOTRANFERASE (AST)K895999PHOSPHORUSK896001ALANINE AMINOTRANSFERASE (ALT)K895423ACCESS CHEMISTRY ANALYZERK893137EXCEL (TM) CHEMISTRY ANALYZERK892331ENZYMATIC UREA NITROGEN REAGENT SET

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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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