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FDA 510(k)

SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM

K-Number: K973742 · 1997-12-03

ApplicantSendx Medical, Inc.
Decision Date1997-12-03
Product CodeCGZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sendx Medical, Inc.. It received FDA 510(k) clearance on 1997-12-03 under 510(k) number K973742. The device is classified under product code CGZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM?

SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1997-12-03. The listed applicant is Sendx Medical, Inc.. The 510(k) number is K973742.

When did SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM receive FDA 510(k) clearance?

SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM received FDA 510(k) clearance on 1997-12-03, under 510(k) number K973742.

Who is the listed applicant for SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM?

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

What is the FDA product code for SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM?

The FDA product code for SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM is CGZ.

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Other records listing Sendx 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.

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Official Source

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