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FDA 510(k)

OXIFLOW DIGITAL RECORDER

K-Number: K953363 · 1996-02-06

ApplicantEdentec Corp.
Decision Date1996-02-06
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

OXIFLOW DIGITAL RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Edentec Corp.. It received FDA 510(k) clearance on 1996-02-06 under 510(k) number K953363. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the OXIFLOW DIGITAL RECORDER?

OXIFLOW DIGITAL RECORDER is a medical device that received FDA 510(k) clearance on 1996-02-06. The listed applicant is Edentec Corp.. The 510(k) number is K953363.

When did OXIFLOW DIGITAL RECORDER receive FDA 510(k) clearance?

OXIFLOW DIGITAL RECORDER received FDA 510(k) clearance on 1996-02-06, under 510(k) number K953363.

Who is the listed applicant for OXIFLOW DIGITAL RECORDER?

The FDA 510(k) record lists Edentec Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OXIFLOW DIGITAL RECORDER?

The FDA product code for OXIFLOW DIGITAL RECORDER is BZQ.

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Other records listing Edentec Corp. 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.

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Official Source

View on FDA Database →

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

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