510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K981655Substantially Equivalent

Spacelabs Medical Disposable Sp02 Sensor

GE Healthcare, Redmond WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981655 is the FDA 510(k) clearance record for SPACELABS MEDICAL DISPOSABLE SP02 SENSOR, a class II device, cleared for Spacelabs Medical, Inc. on under FDA product code DQA (Oximeter). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K981655.

Clearance record

Decision date
Received
(571 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Spacelabs Medical, Inc. P.O. Box 97013, Redmond WA
510(k) summary
Summary
Third party review
No

Clearances, product code DQA

Trailing 12 months
11 clearances under product code DQA in the twelve months to November 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQA, trailing twelve months
MonthClearances
December 20253
January 20261
February 20262
March 20260
April 20261
May 20263
June 20260
July 20260
August 20260
September 20260
October 20261
November 20260