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FDA 510(k)

MODEL 3500 MR-COMPATIBLE PULSE OXIMETER

K-Number: K924285 · 1993-05-11

ApplicantMagnetic Resonance Equipment Corp.
Decision Date1993-05-11
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 3500 MR-COMPATIBLE PULSE OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Magnetic Resonance Equipment Corp.. It received FDA 510(k) clearance on 1993-05-11 under 510(k) number K924285. 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 MODEL 3500 MR-COMPATIBLE PULSE OXIMETER?

MODEL 3500 MR-COMPATIBLE PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 1993-05-11. The listed applicant is Magnetic Resonance Equipment Corp.. The 510(k) number is K924285.

When did MODEL 3500 MR-COMPATIBLE PULSE OXIMETER receive FDA 510(k) clearance?

MODEL 3500 MR-COMPATIBLE PULSE OXIMETER received FDA 510(k) clearance on 1993-05-11, under 510(k) number K924285.

Who is the listed applicant for MODEL 3500 MR-COMPATIBLE PULSE OXIMETER?

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

What is the FDA product code for MODEL 3500 MR-COMPATIBLE PULSE OXIMETER?

The FDA product code for MODEL 3500 MR-COMPATIBLE PULSE OXIMETER is DQA.

Related Clinical Trials

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.

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Other records listing Magnetic Resonance Equipment 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.

K003982TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITORK983250INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITORK954120MODEL 9500 MR-COMPATIBLE MULTIGAS MONITORK924282MODEL 320 MR-COMPATIBLE PULSE OXIMETER

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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