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FDA 510(k)

MANTRA COMBO, MODEL MECS 320

K-Number: K091236 · 2009-07-30

ApplicantMantra Intl. (Hk) , Ltd.
Decision Date2009-07-30
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MANTRA COMBO, MODEL MECS 320 is the device name listed in this FDA 510(k) record. The listed applicant is Mantra Intl. (Hk) , Ltd.. It received FDA 510(k) clearance on 2009-07-30 under 510(k) number K091236. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANTRA COMBO, MODEL MECS 320?

MANTRA COMBO, MODEL MECS 320 is a medical device that received FDA 510(k) clearance on 2009-07-30. The listed applicant is Mantra Intl. (Hk) , Ltd.. The 510(k) number is K091236.

When did MANTRA COMBO, MODEL MECS 320 receive FDA 510(k) clearance?

MANTRA COMBO, MODEL MECS 320 received FDA 510(k) clearance on 2009-07-30, under 510(k) number K091236.

Who is the listed applicant for MANTRA COMBO, MODEL MECS 320?

The FDA 510(k) record lists Mantra Intl. (Hk) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MANTRA COMBO, MODEL MECS 320?

The FDA product code for MANTRA COMBO, MODEL MECS 320 is GZJ.

Related Clinical Trials

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Other records listing Mantra Intl. (Hk) , Ltd. 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.

K041902MANTRA ELECTRODEK041520MANTRA TENS MODEL NT3

Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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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