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FDA 510(k)

COLD CD ASP MODULE, ITE

K-Number: K933041 · 1993-08-02

ApplicantElectone, Inc.
Decision Date1993-08-02
Product CodeLRS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COLD CD ASP MODULE, ITE is the device name listed in this FDA 510(k) record. The listed applicant is Electone, Inc.. It received FDA 510(k) clearance on 1993-08-02 under 510(k) number K933041. The device is classified under product code LRS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLD CD ASP MODULE, ITE?

COLD CD ASP MODULE, ITE is a medical device that received FDA 510(k) clearance on 1993-08-02. The listed applicant is Electone, Inc.. The 510(k) number is K933041.

When did COLD CD ASP MODULE, ITE receive FDA 510(k) clearance?

COLD CD ASP MODULE, ITE received FDA 510(k) clearance on 1993-08-02, under 510(k) number K933041.

Who is the listed applicant for COLD CD ASP MODULE, ITE?

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

What is the FDA product code for COLD CD ASP MODULE, ITE?

The FDA product code for COLD CD ASP MODULE, ITE is LRS.

Related Clinical Trials

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Other records listing Electone, Inc. 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.

K973266Z DEQ-IIK961084AM 400K955702SONATA U-01K953050Z33K953047Z20K953051Z35

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Related Devices (Code: LRS)

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.

K050654AMSINO I.V. START KITAmsino International, Inc.K001879INFUSION IV SETNirvi Intl. USAK963722IV START KITGrand Medical ProductsK951167EMS I.V. START KITEmergency Medical Supply, Inc.K950184B. BRAUN IV START KITSB. Braun of America, Inc.K944041PERSONAL HEARING SYSTEMResound Corp.

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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