# K993512: Datex-Ohmeda Tuffsat 3000 Pulse Oximeter

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Mar 31, 2000 after 165 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ohmeda 3770/3775 Handheld Pulse Oximeters: named in the summary without a submission number

## Indications for use
The Datex-Ohmeda TuffSat 3000 Pulse Oximeter is a non-invasive, spot-check, oxygen saturation and pulse rate monitor. It operates only on battery power using existing Datex-Ohmeda disposable and reusable finger and ear sensors labeled for patients ranging from neonates to adults. US federal and Canadian laws restrict the sale of this device by or on the order of a licensed medical practitioner.

Source page: https://510kreport.com/device/K993512
Methodology: https://510kreport.com/methodology