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FDA 510(k)

ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES

K-Number: K070193 · 2007-05-02

ApplicantEnvitec-Wismar GmbH
Decision Date2007-05-02
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Envitec-Wismar GmbH. It received FDA 510(k) clearance on 2007-05-02 under 510(k) number K070193. 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 ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES?

ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2007-05-02. The listed applicant is Envitec-Wismar GmbH. The 510(k) number is K070193.

When did ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES receive FDA 510(k) clearance?

ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES received FDA 510(k) clearance on 2007-05-02, under 510(k) number K070193.

Who is the listed applicant for ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES?

The FDA 510(k) record lists Envitec-Wismar GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES?

The FDA product code for ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES is DQA.

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Other records listing Envitec-Wismar GmbH 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.

K122290ENVITEC MYSIGN O OXYGEN MEASURING DEVICEK102270ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDENK090438REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSORK082655ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106K060675ENVITEC REUSABLE SOFTIP Y SPO2 SENSORSK043463ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS

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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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