510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103584Substantially Equivalent

Envisen Nellcor, Bci, Nonin, Csi, Hp/philips, Datex-Ohmeda Compatible Disposable and Reusable Spo2 Sensors

Shenzhen Envisen Industry Co. Ltd., Egale WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103584 is the FDA 510(k) clearance record for ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS, a class II device, cleared for Shenzhen Envisen Industry Co. Limited on under FDA product code DQA (Oximeter). FDA records list 2 510(k) clearances for Shenzhen Envisen Industry Co. Limited, from to . As of , FDA records show no recalls naming K103584.

Clearance record

Decision date
Received
(185 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Shenzhen Envisen Industry Co. Limited S65w35739 Piper Rd., Egale WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQA

Trailing 12 months
12 clearances under product code DQA in the twelve months to October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQA, trailing twelve months
MonthClearances
November 20252
December 20253
January 20261
February 20262
March 20260
April 20261
May 20263
June 20260
July 20260
August 20260
September 20260
October 20260