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FDA 510(k)

SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT)

K-Number: K920966 · 1993-07-16

ApplicantAristo Medical Products, Inc.
Decision Date1993-07-16
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT) is the device name listed in this FDA 510(k) record. The listed applicant is Aristo Medical Products, Inc.. It received FDA 510(k) clearance on 1993-07-16 under 510(k) number K920966. 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 SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT)?

SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT) is a medical device that received FDA 510(k) clearance on 1993-07-16. The listed applicant is Aristo Medical Products, Inc.. The 510(k) number is K920966.

When did SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT) receive FDA 510(k) clearance?

SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT) received FDA 510(k) clearance on 1993-07-16, under 510(k) number K920966.

Who is the listed applicant for SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT)?

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

What is the FDA product code for SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT)?

The FDA product code for SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT) is DQA.

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Other records listing Aristo Medical Products, Inc. as applicant

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Official Source

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