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FDA 510(k)

CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE

K-Number: K893867 · 1989-09-13

ApplicantSpacelabs, Inc.
Decision Date1989-09-13
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs, Inc.. It received FDA 510(k) clearance on 1989-09-13 under 510(k) number K893867. 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 CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE?

CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE is a medical device that received FDA 510(k) clearance on 1989-09-13. The listed applicant is Spacelabs, Inc.. The 510(k) number is K893867.

When did CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE receive FDA 510(k) clearance?

CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE received FDA 510(k) clearance on 1989-09-13, under 510(k) number K893867.

Who is the listed applicant for CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE?

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

What is the FDA product code for CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE?

The FDA product code for CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE is DQA.

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Other records listing Spacelabs, Inc. as applicant

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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

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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