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FDA 510(k)

EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS.

K-Number: K884614 · 1989-02-01

ApplicantEdentec Corp.
Decision Date1989-02-01
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS. is the device name listed in this FDA 510(k) record. The listed applicant is Edentec Corp.. It received FDA 510(k) clearance on 1989-02-01 under 510(k) number K884614. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS.?

EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS. is a medical device that received FDA 510(k) clearance on 1989-02-01. The listed applicant is Edentec Corp.. The 510(k) number is K884614.

When did EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS. receive FDA 510(k) clearance?

EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS. received FDA 510(k) clearance on 1989-02-01, under 510(k) number K884614.

Who is the listed applicant for EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS.?

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 EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS.?

The FDA product code for EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS. is DQA.

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Other records listing Edentec Corp. as applicant

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Related Devices (Code: DQA)

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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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