FDA 510(k)

DX1

K-Number: K951227 · 1995-08-11

Decision Date1995-08-11

Product CodeBZG

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

DX1 is the device name listed in this FDA 510(k) record. The listed applicant is Creative Biomedics, Inc.. It received FDA 510(k) clearance on 1995-08-11 under 510(k) number K951227. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DX1?

DX1 is a medical device that received FDA 510(k) clearance on 1995-08-11. The listed applicant is Creative Biomedics, Inc.. The 510(k) number is K951227.

When did DX1 receive FDA 510(k) clearance?

DX1 received FDA 510(k) clearance on 1995-08-11, under 510(k) number K951227.

Who is the listed applicant for DX1?

The FDA 510(k) record lists Creative Biomedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DX1?

The FDA product code for DX1 is BZG.

Other records listing Creative Biomedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K964939THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS K951157DX1-PORTABLE K951410DISPOSABLE PULMONARY FUNCTION FILTER

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.