FDA 510(k)

ABR-2000

K-Number: K020360 · 2002-08-29

Decision Date2002-08-29

Product CodeGZO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ABR-2000 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 2002-08-29 under 510(k) number K020360. 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 ABR-2000?

ABR-2000 is a medical device that received FDA 510(k) clearance on 2002-08-29. The listed applicant is Meridian Co., Ltd.. The 510(k) number is K020360.

When did ABR-2000 receive FDA 510(k) clearance?

ABR-2000 received FDA 510(k) clearance on 2002-08-29, under 510(k) number K020360.

Who is the listed applicant for ABR-2000?

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 ABR-2000?

The FDA product code for ABR-2000 is GZO.

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.

K102375LUCIA K081962LAPEX BCS K034009LAPEX 2000 K023238MCPULSE K010897MERIDIAN-PORTABLE K001347MERIDIAN-II AND MERDIAN-PLUS

View all 7 devices →

Related Devices (Code: GZO)

K131568SUDO PATHLd Technology, LLC K111308ZYTO HAND CRADLEZyto Technologies, Inc.K102166ELECTRO INTERSTITIAL SCANLd Technology, LLC K100233SUDOSCANImpeto Medical K053004MSAS-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.