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FDA 510(k)

OXISCAN II DATA MANAGEMENT SYSTEM

K-Number: K080348 · 2008-10-09

ApplicantAirsep Corp.
Decision Date2008-10-09
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OXISCAN II DATA MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Airsep Corp.. It received FDA 510(k) clearance on 2008-10-09 under 510(k) number K080348. 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 OXISCAN II DATA MANAGEMENT SYSTEM?

OXISCAN II DATA MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-10-09. The listed applicant is Airsep Corp.. The 510(k) number is K080348.

When did OXISCAN II DATA MANAGEMENT SYSTEM receive FDA 510(k) clearance?

OXISCAN II DATA MANAGEMENT SYSTEM received FDA 510(k) clearance on 2008-10-09, under 510(k) number K080348.

Who is the listed applicant for OXISCAN II DATA MANAGEMENT SYSTEM?

The FDA 510(k) record lists Airsep Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OXISCAN II DATA MANAGEMENT SYSTEM?

The FDA product code for OXISCAN II DATA MANAGEMENT SYSTEM is DQA.

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Other records listing Airsep 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.

K101154CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-LK020324LIFESTYLE OXYGEN CONCENTRATORK012037HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009K000963DA VINCHI EEG AND EMG/EP SYSTEMSK001579IMPULSE SELECTK001467DA VINCHI EMG/EP ISA1004EP

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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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