SENSILASE PAD 3000— 510(k) K040654

Substantially Equivalent

Optical Sensors, Inc.

FDA 510(k) clearance K040654 for SENSILASE PAD 3000, Substantially Equivalent on 2004-06-04. Applicant: Optical Sensors, Inc.. Device class: 2.

Clearance details

Applicant: Optical Sensors, Inc.
Product code: Code DPW
Device class: Class 2
Regulation: 21 CFR 870.2100
Advisory panel: Cardiovascular
Date received: 2004-03-12
Decision date: 2004-06-04
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Stoughton, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DPW

K260700 — BlueDop Vascular Expert2026-07-08
K252810 — FloPatch FP1202026-04-24
K251904 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01) +1 more2025-11-20
K251114 — FloPatch FP1202025-06-20
K243852 — Elfor-L2025-04-14

More clearances from Optical Sensors, Inc.

K010795 — CAPNOPROBE SL, MODEL 20002001-04-11
K984579 — CAPNO PROBE A2000-12-21
K961790 — POINT-OF-CARE BLOOD GAS MONITOR SYSTEM1997-04-09
K963935 — OLYMPUS CRITICAL CARE MONITORING SYSTEM1997-01-23
K951094 — POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM1996-01-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.