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FDA 510(k)

DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.)

K-Number: K901956 · 1990-07-02

ApplicantEigen
Decision Date1990-07-02
Product CodeLMB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.) is the device name listed in this FDA 510(k) record. The listed applicant is Eigen. It received FDA 510(k) clearance on 1990-07-02 under 510(k) number K901956. The device is classified under product code LMB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.)?

DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.) is a medical device that received FDA 510(k) clearance on 1990-07-02. The listed applicant is Eigen. The 510(k) number is K901956.

When did DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.) receive FDA 510(k) clearance?

DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.) received FDA 510(k) clearance on 1990-07-02, under 510(k) number K901956.

Who is the listed applicant for DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.)?

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

What is the FDA product code for DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.)?

The FDA product code for DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.) is LMB.

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Other records listing Eigen 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.

K222222Artemis, Artemis TPO, Artemis MXK173744ProFuse CADK162474ArtemisK063846EIGEN DSA 2000K933115DIGITAL DISK RECORDERK924164DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT

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Related Devices (Code: LMB)

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K992131SAMSUNG RAYPAX LONG TERM ARCHIVESamsung Sds Co., Ltd.K984405ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000Intracom Corp.K983447WISE (II) IMAGE MANAGEMENT SYSTEMSectra-Imtec ABK980243PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)Parameter Developments, Inc.K973463OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVEO Tech, Inc.K973413ID. STORE (RELEASE 2.0)I.S.G. Technologies, 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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