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FDA 510(k)

DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS

K-Number: K983684 · 1998-11-06

ApplicantDatex-Ohmeda, Inc.
Decision Date1998-11-06
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS 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 1998-11-06 under 510(k) number K983684. 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 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS?

DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS is a medical device that received FDA 510(k) clearance on 1998-11-06. The listed applicant is Datex-Ohmeda, Inc.. The 510(k) number is K983684.

When did DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS receive FDA 510(k) clearance?

DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS received FDA 510(k) clearance on 1998-11-06, under 510(k) number K983684.

Who is the listed applicant for DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS?

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 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS?

The FDA product code for DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS is 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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