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FDA 510(k)

EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM.

K-Number: K893561 · 1989-08-25

ApplicantEdentec Corp.
Decision Date1989-08-25
Product CodeDSF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. is the device name listed in this FDA 510(k) record. The listed applicant is Edentec Corp.. It received FDA 510(k) clearance on 1989-08-25 under 510(k) number K893561. The device is classified under product code DSF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM.?

EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. is a medical device that received FDA 510(k) clearance on 1989-08-25. The listed applicant is Edentec Corp.. The 510(k) number is K893561.

When did EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. receive FDA 510(k) clearance?

EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. received FDA 510(k) clearance on 1989-08-25, under 510(k) number K893561.

Who is the listed applicant for EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM.?

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 EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM.?

The FDA product code for EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. is DSF.

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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.

K953363OXIFLOW DIGITAL RECORDERK953540EEEK921819EDENTEC MODEL 3710 I DIGITAL PRINTERK913749EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170K910871EDENTEC DIGITAL CHARTER MODEL 3710K910870EDENTEC MODEL 3711 DIGITAL RECORDER

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Related Devices (Code: DSF)

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.

K910871EDENTEC DIGITAL CHARTER MODEL 3710Edentec Corp.K912929DASH IVAstro-Med, Inc.K905856MODEL 556 MONITORGe Medical Systems Information TechnologiesK902586GRI LASERGRAPH(TM) ECG PAPERGri Medical Products, Inc.K902230COLORADO COLOR IMAGING RECORDERHoneywell, Inc.K901385GABRIEL MEDICAL CLS THERMAL RECORDERGabriel Medical, Inc.

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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