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FDA 510(k)

SENDX 100 PH, BLOOD GAS & ELECTROLYTE ANALYSIS SYSTEM

K-Number: K954482 · 1995-12-04

ApplicantCirrus Medical,Inc.
Decision Date1995-12-04
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SENDX 100 PH, BLOOD GAS & ELECTROLYTE ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cirrus Medical,Inc.. It received FDA 510(k) clearance on 1995-12-04 under 510(k) number K954482. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

SENDX 100 PH, BLOOD GAS & ELECTROLYTE ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1995-12-04. The listed applicant is Cirrus Medical,Inc.. The 510(k) number is K954482.

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

SENDX 100 PH, BLOOD GAS & ELECTROLYTE ANALYSIS SYSTEM received FDA 510(k) clearance on 1995-12-04, under 510(k) number K954482.

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

The FDA 510(k) record lists Cirrus 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 & ELECTROLYTE ANALYSIS SYSTEM?

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

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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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