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FDA 510(k)

MODEL 405T WITH ETCO2 OPTION

K-Number: K964961 · 1997-05-14

ApplicantIvy Biomedical Systems, Inc.
Decision Date1997-05-14
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL 405T WITH ETCO2 OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Ivy Biomedical Systems, Inc.. It received FDA 510(k) clearance on 1997-05-14 under 510(k) number K964961. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 405T WITH ETCO2 OPTION?

MODEL 405T WITH ETCO2 OPTION is a medical device that received FDA 510(k) clearance on 1997-05-14. The listed applicant is Ivy Biomedical Systems, Inc.. The 510(k) number is K964961.

When did MODEL 405T WITH ETCO2 OPTION receive FDA 510(k) clearance?

MODEL 405T WITH ETCO2 OPTION received FDA 510(k) clearance on 1997-05-14, under 510(k) number K964961.

Who is the listed applicant for MODEL 405T WITH ETCO2 OPTION?

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

What is the FDA product code for MODEL 405T WITH ETCO2 OPTION?

The FDA product code for MODEL 405T WITH ETCO2 OPTION is CCK.

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Related Devices (Code: CCK)

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

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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