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FDA 510(k)

THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS

K-Number: K964939 · 1997-03-06

ApplicantCreative Biomedics, Inc.
Decision Date1997-03-06
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS 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 1997-03-06 under 510(k) number K964939. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS?

THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS is a medical device that received FDA 510(k) clearance on 1997-03-06. The listed applicant is Creative Biomedics, Inc.. The 510(k) number is K964939.

When did THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS receive FDA 510(k) clearance?

THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS received FDA 510(k) clearance on 1997-03-06, under 510(k) number K964939.

Who is the listed applicant for THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS?

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 THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS?

The FDA product code for THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS is BZC.

Related Clinical Trials

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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.

K951227DX1K951157DX1-PORTABLEK951410DISPOSABLE PULMONARY FUNCTION FILTER

Related Devices (Code: BZC)

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.

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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.

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