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FDA 510(k)

MODEL OX-1 OXYGEN SATURATION MODULE

K-Number: K884822 · 1989-03-02

ApplicantColin Medical Instruments Corp.
Decision Date1989-03-02
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL OX-1 OXYGEN SATURATION MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Colin Medical Instruments Corp.. It received FDA 510(k) clearance on 1989-03-02 under 510(k) number K884822. 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 MODEL OX-1 OXYGEN SATURATION MODULE?

MODEL OX-1 OXYGEN SATURATION MODULE is a medical device that received FDA 510(k) clearance on 1989-03-02. The listed applicant is Colin Medical Instruments Corp.. The 510(k) number is K884822.

When did MODEL OX-1 OXYGEN SATURATION MODULE receive FDA 510(k) clearance?

MODEL OX-1 OXYGEN SATURATION MODULE received FDA 510(k) clearance on 1989-03-02, under 510(k) number K884822.

Who is the listed applicant for MODEL OX-1 OXYGEN SATURATION MODULE?

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

What is the FDA product code for MODEL OX-1 OXYGEN SATURATION MODULE?

The FDA product code for MODEL OX-1 OXYGEN SATURATION MODULE is DQA.

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Related Devices (Code: DQA)

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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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