ULTIMA BODY POSITION SENSOR— 510(k) K981969

Name: FDA 510(k) clearance K981969
Creator: U.S. Food and Drug Administration
Published: 1998-08-20

Substantially Equivalent

Braebon Medical Corp.

FDA 510(k) clearance K981969 for ULTIMA BODY POSITION SENSOR, Substantially Equivalent on 1998-08-20. Applicant: Braebon Medical Corp.. Device class: 2.

Clearance details

Applicant: Braebon Medical Corp.
Product code: Code LEL
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 1998-06-04
Decision date: 1998-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kanata, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code LEL

view all

K252981 — EmbraceMini2025-12-22
K251574 — Sleep Watch2025-07-31
K243513 — DCM (PW-DCM)2025-04-16
K233987 — VERABAND2024-06-17
K233618 — Oxevision Sleep Device2024-04-03

More clearances from Braebon Medical Corp.

view all

K061764 — MEDIBYTE, MODEL MP82006-09-06
K031202 — MEDIPALM-202003-05-01
K020312 — ULTIMA SNORING MIKE, MODEL 05402002-08-07
K001743 — ULTIMA SMARTBELT, MODEL 05602000-08-25
K984431 — ULTIMA AIRFLOW PRESSURE SENSOR1998-12-30

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