Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS

K-Number: K852178 · 1985-12-27

Decision Date1985-12-27
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS is the device name listed in this FDA 510(k) record. The listed applicant is American Omni Medical, Inc.. It received FDA 510(k) clearance on 1985-12-27 under 510(k) number K852178. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS?

EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS is a medical device that received FDA 510(k) clearance on 1985-12-27. The listed applicant is American Omni Medical, Inc.. The 510(k) number is K852178.

When did EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS receive FDA 510(k) clearance?

EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS received FDA 510(k) clearance on 1985-12-27, under 510(k) number K852178.

Who is the listed applicant for EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS?

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

What is the FDA product code for EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS?

The FDA product code for EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS is CAC.

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 American Omni Medical, 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.

View all 20 devices →

Related Devices (Code: CAC)

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

View on FDA Database →

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

↑