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FDA 510(k)

BUBBLE TRAP CAT. NO. B-180

K-Number: K870819 · 1987-06-08

ApplicantAmerican Omni Medical, Inc.
Decision Date1987-06-08
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BUBBLE TRAP CAT. NO. B-180 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 1987-06-08 under 510(k) number K870819. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUBBLE TRAP CAT. NO. B-180?

BUBBLE TRAP CAT. NO. B-180 is a medical device that received FDA 510(k) clearance on 1987-06-08. The listed applicant is American Omni Medical, Inc.. The 510(k) number is K870819.

When did BUBBLE TRAP CAT. NO. B-180 receive FDA 510(k) clearance?

BUBBLE TRAP CAT. NO. B-180 received FDA 510(k) clearance on 1987-06-08, under 510(k) number K870819.

Who is the listed applicant for BUBBLE TRAP CAT. NO. B-180?

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 BUBBLE TRAP CAT. NO. B-180?

The FDA product code for BUBBLE TRAP CAT. NO. B-180 is DWF.

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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.

K922781FLOW CONROL VALVEK922356FLOW CONTROL VALVE, CAT. NO. ACV-38K900672PREBYPASS FILTER, CAT. NO. FPB-5K884893CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25K884640CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700K873316BUBBLE TRAP-FILTER CAT. NO B180F37

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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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