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FDA 510(k)

SMARTSAT PULSE OXIMETRY ANALYZER

K-Number: K952327 · 1995-08-25

ApplicantClinical Dynamics Corp.
Decision Date1995-08-25
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SMARTSAT PULSE OXIMETRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Dynamics Corp.. It received FDA 510(k) clearance on 1995-08-25 under 510(k) number K952327. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTSAT PULSE OXIMETRY ANALYZER?

SMARTSAT PULSE OXIMETRY ANALYZER is a medical device that received FDA 510(k) clearance on 1995-08-25. The listed applicant is Clinical Dynamics Corp.. The 510(k) number is K952327.

When did SMARTSAT PULSE OXIMETRY ANALYZER receive FDA 510(k) clearance?

SMARTSAT PULSE OXIMETRY ANALYZER received FDA 510(k) clearance on 1995-08-25, under 510(k) number K952327.

Who is the listed applicant for SMARTSAT PULSE OXIMETRY ANALYZER?

The FDA 510(k) record lists Clinical Dynamics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTSAT PULSE OXIMETRY ANALYZER?

The FDA product code for SMARTSAT PULSE OXIMETRY ANALYZER is DQA.

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Related Devices (Code: DQA)

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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