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FDA 510(k)

EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER

K-Number: K881820 · 1988-07-18

ApplicantEdentec Corp.
Decision Date1988-07-18
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Edentec Corp.. It received FDA 510(k) clearance on 1988-07-18 under 510(k) number K881820. 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 2800/2801 OXIMETER/PULSE OXIMETER?

EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 1988-07-18. The listed applicant is Edentec Corp.. The 510(k) number is K881820.

When did EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER receive FDA 510(k) clearance?

EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER received FDA 510(k) clearance on 1988-07-18, under 510(k) number K881820.

Who is the listed applicant for EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER?

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 2800/2801 OXIMETER/PULSE OXIMETER?

The FDA product code for EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER is DQA.

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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 3170K910870EDENTEC MODEL 3711 DIGITAL RECORDERK910871EDENTEC DIGITAL CHARTER MODEL 3710

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Related Devices (Code: DQA)

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.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

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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