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FDA 510(k)

SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE

K-Number: K952315 · 1996-12-04

ApplicantEmg Scientific
Decision Date1996-12-04
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Emg Scientific. It received FDA 510(k) clearance on 1996-12-04 under 510(k) number K952315. 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 SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE?

SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE is a medical device that received FDA 510(k) clearance on 1996-12-04. The listed applicant is Emg Scientific. The 510(k) number is K952315.

When did SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE receive FDA 510(k) clearance?

SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE received FDA 510(k) clearance on 1996-12-04, under 510(k) number K952315.

Who is the listed applicant for SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE?

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

What is the FDA product code for SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE?

The FDA product code for SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE is DQA.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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