Cleared Special

K983684 - DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P...

K983684 is an FDA 510(k) clearance for DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P..., manufactured by Datex-Ohmeda, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 17-day FDA review.

K983684 · Datex-Ohmeda, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
17d
Days
Class 2
Risk

K983684 is an FDA 510(k) clearance for the DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Datex-Ohmeda, Inc. (Louisville, US). The FDA issued a Cleared decision on November 6, 1998 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Datex-Ohmeda, Inc. devices

FDA 510(k) Submission Details - K983684

510(k) Number K983684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1998
Decision Date November 06, 1998
Days to Decision 17 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 140d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 453
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