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FDA 510(k)

DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER

K-Number: K993512 · 2000-03-31

ApplicantDatex-Ohmeda, Inc.
Decision Date2000-03-31
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Datex-Ohmeda, Inc.. It received FDA 510(k) clearance on 2000-03-31 under 510(k) number K993512. 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 DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER?

DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 2000-03-31. The listed applicant is Datex-Ohmeda, Inc.. The 510(k) number is K993512.

When did DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER receive FDA 510(k) clearance?

DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER received FDA 510(k) clearance on 2000-03-31, under 510(k) number K993512.

Who is the listed applicant for DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER?

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

What is the FDA product code for DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER?

The FDA product code for DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER 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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