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FDA 510(k)

CALDYNE, INC. EXHALOMETER EX100, MODEL EX100

K-Number: K051279 · 2005-09-07

ApplicantCaldyne, Inc.
Decision Date2005-09-07
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CALDYNE, INC. EXHALOMETER EX100, MODEL EX100 is the device name listed in this FDA 510(k) record. The listed applicant is Caldyne, Inc.. It received FDA 510(k) clearance on 2005-09-07 under 510(k) number K051279. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALDYNE, INC. EXHALOMETER EX100, MODEL EX100?

CALDYNE, INC. EXHALOMETER EX100, MODEL EX100 is a medical device that received FDA 510(k) clearance on 2005-09-07. The listed applicant is Caldyne, Inc.. The 510(k) number is K051279.

When did CALDYNE, INC. EXHALOMETER EX100, MODEL EX100 receive FDA 510(k) clearance?

CALDYNE, INC. EXHALOMETER EX100, MODEL EX100 received FDA 510(k) clearance on 2005-09-07, under 510(k) number K051279.

Who is the listed applicant for CALDYNE, INC. EXHALOMETER EX100, MODEL EX100?

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

What is the FDA product code for CALDYNE, INC. EXHALOMETER EX100, MODEL EX100?

The FDA product code for CALDYNE, INC. EXHALOMETER EX100, MODEL EX100 is BZK.

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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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