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FDA 510(k)

MAXI-SCOPE OR ULTRA-SCOPE

K-Number: K912128 · 1991-06-28

ApplicantSeiichi Mfg., Inc.
Decision Date1991-06-28
Product CodeLDE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAXI-SCOPE OR ULTRA-SCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Seiichi Mfg., Inc.. It received FDA 510(k) clearance on 1991-06-28 under 510(k) number K912128. The device is classified under product code LDE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAXI-SCOPE OR ULTRA-SCOPE?

MAXI-SCOPE OR ULTRA-SCOPE is a medical device that received FDA 510(k) clearance on 1991-06-28. The listed applicant is Seiichi Mfg., Inc.. The 510(k) number is K912128.

When did MAXI-SCOPE OR ULTRA-SCOPE receive FDA 510(k) clearance?

MAXI-SCOPE OR ULTRA-SCOPE received FDA 510(k) clearance on 1991-06-28, under 510(k) number K912128.

Who is the listed applicant for MAXI-SCOPE OR ULTRA-SCOPE?

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

What is the FDA product code for MAXI-SCOPE OR ULTRA-SCOPE?

The FDA product code for MAXI-SCOPE OR ULTRA-SCOPE is LDE.

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Related Devices (Code: LDE)

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.

K945082CYPRESS MEDICAL PRODUCTS STETHOSCOPECypress Medical Products, Ltd.K944337VARIOUS STETHOSCOPESRud Riester GmbH & CO KGK940578MANUAL STETOSCOPEBhs Intl., Inc.K935944PROSCOPES AND ADSCOPESAmerican Diagnostic Corp.K923327STETHOSCOPE COVERAnup Chakraborty Co.K924095TIMEOSCOPE AND FLEXISCOPEStethoscopes of America, Inc.

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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