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FDA 510(k)

CO BREATH ANALYSIS MODULE & MONOXOL II

K-Number: K952694 · 1996-01-29

ApplicantBacharach, Inc.
Decision Date1996-01-29
Product CodeCCJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CO BREATH ANALYSIS MODULE & MONOXOL II is the device name listed in this FDA 510(k) record. The listed applicant is Bacharach, Inc.. It received FDA 510(k) clearance on 1996-01-29 under 510(k) number K952694. The device is classified under product code CCJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CO BREATH ANALYSIS MODULE & MONOXOL II?

CO BREATH ANALYSIS MODULE & MONOXOL II is a medical device that received FDA 510(k) clearance on 1996-01-29. The listed applicant is Bacharach, Inc.. The 510(k) number is K952694.

When did CO BREATH ANALYSIS MODULE & MONOXOL II receive FDA 510(k) clearance?

CO BREATH ANALYSIS MODULE & MONOXOL II received FDA 510(k) clearance on 1996-01-29, under 510(k) number K952694.

Who is the listed applicant for CO BREATH ANALYSIS MODULE & MONOXOL II?

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

What is the FDA product code for CO BREATH ANALYSIS MODULE & MONOXOL II?

The FDA product code for CO BREATH ANALYSIS MODULE & MONOXOL II is CCJ.

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Related Devices (Code: CCJ)

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.

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Official Source

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

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