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FDA 510(k)

MERIDIAN-PORTABLE

K-Number: K010897 · 2001-06-19

ApplicantMeridian Co., Ltd.
Decision Date2001-06-19
Product CodeGZO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MERIDIAN-PORTABLE is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Co., Ltd.. It received FDA 510(k) clearance on 2001-06-19 under 510(k) number K010897. The device is classified under product code GZO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MERIDIAN-PORTABLE?

MERIDIAN-PORTABLE is a medical device that received FDA 510(k) clearance on 2001-06-19. The listed applicant is Meridian Co., Ltd.. The 510(k) number is K010897.

When did MERIDIAN-PORTABLE receive FDA 510(k) clearance?

MERIDIAN-PORTABLE received FDA 510(k) clearance on 2001-06-19, under 510(k) number K010897.

Who is the listed applicant for MERIDIAN-PORTABLE?

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

What is the FDA product code for MERIDIAN-PORTABLE?

The FDA product code for MERIDIAN-PORTABLE is GZO.

Related Clinical Trials

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Other records listing Meridian Co., 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.

K102375LUCIAK081962LAPEX BCSK034009LAPEX 2000K023238MCPULSEK020360ABR-2000K001347MERIDIAN-II AND MERDIAN-PLUS

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Related Devices (Code: GZO)

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.

K131568SUDO PATHLd Technology, LLCK111308ZYTO HAND CRADLEZyto Technologies, Inc.K102166ELECTRO INTERSTITIAL SCANLd Technology, LLCK100233SUDOSCANImpeto MedicalK053004MSAS-VANTAGEBiomeridian, Int.K032935EPI-SCAN, MODEL P 100Edx Epi-Scan, Inc.

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.

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