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FDA 510(k)

FIBERSCOPIC SCOPE RECORDER SYSTEM

K-Number: K770782 · 1977-05-06

ApplicantElmed, Inc.
Decision Date1977-05-06
Product CodeGWK
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

FIBERSCOPIC SCOPE RECORDER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Elmed, Inc.. It received FDA 510(k) clearance on 1977-05-06 under 510(k) number K770782. The device is classified under product code GWK. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBERSCOPIC SCOPE RECORDER SYSTEM?

FIBERSCOPIC SCOPE RECORDER SYSTEM is a medical device that received FDA 510(k) clearance on 1977-05-06. The listed applicant is Elmed, Inc.. The 510(k) number is K770782.

When did FIBERSCOPIC SCOPE RECORDER SYSTEM receive FDA 510(k) clearance?

FIBERSCOPIC SCOPE RECORDER SYSTEM received FDA 510(k) clearance on 1977-05-06, under 510(k) number K770782.

Who is the listed applicant for FIBERSCOPIC SCOPE RECORDER SYSTEM?

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

What is the FDA product code for FIBERSCOPIC SCOPE RECORDER SYSTEM?

The FDA product code for FIBERSCOPIC SCOPE RECORDER SYSTEM is GWK.

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Other records listing Elmed, 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.

K010465DENSTATK974793ELMED ESU 120 M/M DIGITALK953271ELMED RF-ALERTK952110ELMED THERMO-FLUXK926517ELMED LBC 50-PK932938ELMED ESU 300 M/M AND DIGITAL

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Related Devices (Code: GWK)

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.

K060919ACTICALRespironics, Inc.K061870VITALSENSE XHRRespironics, Inc.K052489ACTIHEARTRespironics, Inc.K991045MINI-LOGGER SERIES 2000Mini-Mitter Co., Inc.K905594NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300Nihon Kohden America, Inc.K904328VISTA POLYSOMNOGRAPHY COMPUTER SYSTEMTelediagnostic Systems, 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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