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FDA 510(k)

INDEX SPO2 SIMULATOR

K-Number: K933519 · 1994-09-01

ApplicantBio-Tek Instruments, Inc.
Decision Date1994-09-01
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INDEX SPO2 SIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Tek Instruments, Inc.. It received FDA 510(k) clearance on 1994-09-01 under 510(k) number K933519. 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 INDEX SPO2 SIMULATOR?

INDEX SPO2 SIMULATOR is a medical device that received FDA 510(k) clearance on 1994-09-01. The listed applicant is Bio-Tek Instruments, Inc.. The 510(k) number is K933519.

When did INDEX SPO2 SIMULATOR receive FDA 510(k) clearance?

INDEX SPO2 SIMULATOR received FDA 510(k) clearance on 1994-09-01, under 510(k) number K933519.

Who is the listed applicant for INDEX SPO2 SIMULATOR?

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

What is the FDA product code for INDEX SPO2 SIMULATOR?

The FDA product code for INDEX SPO2 SIMULATOR is DQA.

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Other records listing Bio-Tek Instruments, Inc. as applicant

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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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