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FDA 510(k)

SPEAKER-AMPLIFIER & RECORDER INTERFACE

K-Number: K780201 · 1978-03-02

ApplicantL&M Ultrascope Life Monitoring Sys.
Decision Date1978-03-02
Product CodeJAF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SPEAKER-AMPLIFIER & RECORDER INTERFACE is the device name listed in this FDA 510(k) record. The listed applicant is L&M Ultrascope Life Monitoring Sys.. It received FDA 510(k) clearance on 1978-03-02 under 510(k) number K780201. The device is classified under product code JAF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPEAKER-AMPLIFIER & RECORDER INTERFACE?

SPEAKER-AMPLIFIER & RECORDER INTERFACE is a medical device that received FDA 510(k) clearance on 1978-03-02. The listed applicant is L&M Ultrascope Life Monitoring Sys.. The 510(k) number is K780201.

When did SPEAKER-AMPLIFIER & RECORDER INTERFACE receive FDA 510(k) clearance?

SPEAKER-AMPLIFIER & RECORDER INTERFACE received FDA 510(k) clearance on 1978-03-02, under 510(k) number K780201.

Who is the listed applicant for SPEAKER-AMPLIFIER & RECORDER INTERFACE?

The FDA 510(k) record lists L&M Ultrascope Life Monitoring Sys. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPEAKER-AMPLIFIER & RECORDER INTERFACE?

The FDA product code for SPEAKER-AMPLIFIER & RECORDER INTERFACE is JAF.

Related Clinical Trials

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.

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Other records listing L&M Ultrascope Life Monitoring Sys. 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.

K780200ULTRASCOPE

Related Devices (Code: JAF)

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.

K242487Laminar P1 (LDH-HW-001)Laminar Digital Health, Inc.K110628SIMPLEABINewman MedicalK093393LIFEDOP MODEL 300ABISummit Doppler Systems, Inc.K090009THD SLIDE ONEThd SpaK081429THD SLIDEThd SpaK070815THDG.F. S.R.L.

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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