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FDA 510(k)

G1B PULSE OXIMETER

K-Number: K082789 · 2009-01-07

ApplicantGeneral Meditech, Inc.
Decision Date2009-01-07
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

G1B PULSE OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is General Meditech, Inc.. It received FDA 510(k) clearance on 2009-01-07 under 510(k) number K082789. 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 G1B PULSE OXIMETER?

G1B PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 2009-01-07. The listed applicant is General Meditech, Inc.. The 510(k) number is K082789.

When did G1B PULSE OXIMETER receive FDA 510(k) clearance?

G1B PULSE OXIMETER received FDA 510(k) clearance on 2009-01-07, under 510(k) number K082789.

Who is the listed applicant for G1B PULSE OXIMETER?

The FDA 510(k) record lists General Meditech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for G1B PULSE OXIMETER?

The FDA product code for G1B PULSE OXIMETER is DQA.

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Other records listing General Meditech, Inc. 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.

K092970GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H

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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