Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MTEK-1000

K-Number: K982405 · 1998-09-17

ApplicantMagna Advanced Technologies, Inc.
Decision Date1998-09-17
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MTEK-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Magna Advanced Technologies, Inc.. It received FDA 510(k) clearance on 1998-09-17 under 510(k) number K982405. 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 MTEK-1000?

MTEK-1000 is a medical device that received FDA 510(k) clearance on 1998-09-17. The listed applicant is Magna Advanced Technologies, Inc.. The 510(k) number is K982405.

When did MTEK-1000 receive FDA 510(k) clearance?

MTEK-1000 received FDA 510(k) clearance on 1998-09-17, under 510(k) number K982405.

Who is the listed applicant for MTEK-1000?

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

What is the FDA product code for MTEK-1000?

The FDA product code for MTEK-1000 is DQA.

Other records listing Magna Advanced Technologies, 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.

K991819MAGNATEK 30K982907MAGNATEK 40K983114MAGNATEK80K982846MTEK-1400K981310MAGNATEK C-300K981416MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15

View all 7 devices →

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.

↑