# K083351: Proable Pulse Oximeter, Model MD-600P, Traveler Oximeter, Model MD-650P and Palm Pulse Oximeter, Model MD-680P

- Pathway: 510(k) (Traditional)
- Applicant: Comdek Industrial Corp.
- Decided: Apr 24, 2009 after 162 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The COMDEK Portable Pulse Oximeter MD-600P offers non-invasive continuous and instantaneous monitoring, and provides users with high-level accuracy and a quick measuring response. The environments for use are hospitals, intra-hospital transport, hospital-type facilities and the home. The device is intended for use only with adults.

Source page: https://510kreport.com/device/K083351
Methodology: https://510kreport.com/methodology