DX1-PORTABLE— 510(k) K951157

Substantially Equivalent

Creative Biomedics, Inc.

FDA 510(k) clearance K951157 for DX1-PORTABLE, Substantially Equivalent on 1995-08-11. Applicant: Creative Biomedics, Inc.. Device class: 2.

Clearance details

Applicant: Creative Biomedics, Inc.
Product code: Code BZC
Device class: Class 2
Regulation: 21 CFR 868.1880
Advisory panel: Anesthesiology
Date received: 1995-03-14
Decision date: 1995-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Creative Biomedics, Inc.

K964939 — THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS1997-03-06
K951227 — DX11995-08-11
K951410 — DISPOSABLE PULMONARY FUNCTION FILTER1995-04-24

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