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FDA 510(k)

PROASIA, MODEL L3402

K-Number: K052378 · 2005-10-07

ApplicantProasia Limited
Decision Date2005-10-07
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PROASIA, MODEL L3402 is the device name listed in this FDA 510(k) record. The listed applicant is Proasia Limited. It received FDA 510(k) clearance on 2005-10-07 under 510(k) number K052378. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROASIA, MODEL L3402?

PROASIA, MODEL L3402 is a medical device that received FDA 510(k) clearance on 2005-10-07. The listed applicant is Proasia Limited. The 510(k) number is K052378.

When did PROASIA, MODEL L3402 receive FDA 510(k) clearance?

PROASIA, MODEL L3402 received FDA 510(k) clearance on 2005-10-07, under 510(k) number K052378.

Who is the listed applicant for PROASIA, MODEL L3402?

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

What is the FDA product code for PROASIA, MODEL L3402?

The FDA product code for PROASIA, MODEL L3402 is INI.

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 Proasia Limited 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.

K052486PROASIA, MODEL L4501

Related Devices (Code: INI)

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.

K261078Electric Scooter (FNS01,FNS03)Anhui Jbh Medical Apparatus Co., Ltd.K261859Electric Scooter (FDB08, FDB08A, FDB12)Anhui JBH Medical Apparatus Co., Ltd.K260094Mobility Scooter (W3465, W3902 (S50 Carbon))Zhejiang Innuovo Rehabilitation Devices Co.,LtdK260176Mobility Scooter (W3483, W3483A)Zhejiang Innuovo Rehabilitation Devices Co.,LtdK261232IERO Mobility Scooter (IERO-01)Jochu Technology Co., Ltd.K261163Mobility Scooter (R200)Yongkang Ruihe Metal Product Co., Ltd.

Official Source

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