CALIBRATION GAS— 510(k) K944998

Substantially Equivalent

Sunox, Inc.

FDA 510(k) clearance K944998 for CALIBRATION GAS, Substantially Equivalent on 1995-02-03. Applicant: Sunox, Inc.. Device class: 1.

Clearance details

Applicant: Sunox, Inc.
Product code: Code BXK
Device class: Class 1
Regulation: 21 CFR 868.6400
Advisory panel: Anesthesiology
Date received: 1994-10-13
Decision date: 1995-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlotte, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BXK

K954803 — BLOOD GAS MIXTURES1996-01-25
K954804 — LUNG DIFFUSION MIXTURES1996-01-25
K954542 — LUNG DIFFUSION MIXTURE1995-12-22
K952838 — MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES1995-09-19
K953934 — MED-TECH LUNG DIFFUSION MIXTURE1995-09-18

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