Cleared Special

K002690 - MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500 (FDA 510(k) Clearance)

K002690 · Nonin Medical, Inc. · Anesthesiology device

Oct 2000

Decision

43d

Days

Class 2

Risk

K002690 is an FDA 510(k) clearance for the MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on October 11, 2000, 43 days after receiving the submission on August 29, 2000.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number	K002690 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 29, 2000
Decision Date	October 11, 2000
Days to Decision	43 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF