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FDA 510(k)

O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381

K-Number: K822624 · 1982-10-06

ApplicantDel Mar Avionics
Decision Date1982-10-06
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381 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 1982-10-06 under 510(k) number K822624. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381?

O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381 is a medical device that received FDA 510(k) clearance on 1982-10-06. The listed applicant is Del Mar Avionics. The 510(k) number is K822624.

When did O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381 receive FDA 510(k) clearance?

O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381 received FDA 510(k) clearance on 1982-10-06, under 510(k) number K822624.

Who is the listed applicant for O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381?

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 O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381?

The FDA product code for O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381 is IKN.

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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: IKN)

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.

K172743Natus VikingQuestNatus Neurology IncorporatedK163150ViMove2Dorsavi, Ltd.K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.K123902PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)Oktx, LLCK123399MYOVISION 3.0 WIREFREE SYSTEMPrecision Biometrics, Inc.K113074CMAP PROMedical Technologies, 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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