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FDA 510(k)

ENVITEC MYSIGN O OXYGEN MEASURING DEVICE

K-Number: K122290 · 2013-01-23

ApplicantEnvitec-Wismar GmbH
Decision Date2013-01-23
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ENVITEC MYSIGN O OXYGEN MEASURING DEVICE 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 2013-01-23 under 510(k) number K122290. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENVITEC MYSIGN O OXYGEN MEASURING DEVICE?

ENVITEC MYSIGN O OXYGEN MEASURING DEVICE is a medical device that received FDA 510(k) clearance on 2013-01-23. The listed applicant is Envitec-Wismar GmbH. The 510(k) number is K122290.

When did ENVITEC MYSIGN O OXYGEN MEASURING DEVICE receive FDA 510(k) clearance?

ENVITEC MYSIGN O OXYGEN MEASURING DEVICE received FDA 510(k) clearance on 2013-01-23, under 510(k) number K122290.

Who is the listed applicant for ENVITEC MYSIGN O OXYGEN MEASURING DEVICE?

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 MYSIGN O OXYGEN MEASURING DEVICE?

The FDA product code for ENVITEC MYSIGN O OXYGEN MEASURING DEVICE is CCL.

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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.

K102270ENVITEC 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;00M106K070193ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIESK060675ENVITEC REUSABLE SOFTIP Y SPO2 SENSORSK043463ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS

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Related Devices (Code: CCL)

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.

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter LabsK251245OxyMinder Pro (10310)Bio-Med Device, Inc.K250002Smart Check O2 (MA0236)Life Spark Medical, LLCK221734Maxtec MaxO2 ME+pMaxtec, LLCK213933Percent Oxygen SensorsCareox, LLCK213948OxyMinderBio-Med Devices, 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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