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FDA 510(k)

OTE BIOMEDICAL #1296 - 16 CHAN. RECORD

K-Number: K820779 · 1982-04-26

ApplicantDel Mar Avionics
Decision Date1982-04-26
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OTE BIOMEDICAL #1296 - 16 CHAN. RECORD is the device name listed in this FDA 510(k) record. The listed applicant is Del Mar Avionics. It received FDA 510(k) clearance on 1982-04-26 under 510(k) number K820779. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTE BIOMEDICAL #1296 - 16 CHAN. RECORD?

OTE BIOMEDICAL #1296 - 16 CHAN. RECORD is a medical device that received FDA 510(k) clearance on 1982-04-26. The listed applicant is Del Mar Avionics. The 510(k) number is K820779.

When did OTE BIOMEDICAL #1296 - 16 CHAN. RECORD receive FDA 510(k) clearance?

OTE BIOMEDICAL #1296 - 16 CHAN. RECORD received FDA 510(k) clearance on 1982-04-26, under 510(k) number K820779.

Who is the listed applicant for OTE BIOMEDICAL #1296 - 16 CHAN. RECORD?

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

What is the FDA product code for OTE BIOMEDICAL #1296 - 16 CHAN. RECORD?

The FDA product code for OTE BIOMEDICAL #1296 - 16 CHAN. RECORD is GWQ.

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Other records listing Del Mar Avionics 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.

K990027OMNICORDER, MODEL 464K971696SENTINEL RECORDER, MODELS 471/472K963174HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)K950020HOLTER PACERCORDER(R)K942653HOLTER SSR DIGICORDER(TM)K922221SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEM

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Related Devices (Code: GWQ)

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.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity SasK221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, 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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