Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

CIG 1977-05-10

BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR.

Applicant Icn Pharmaceuticals, Inc.

K-Number K770458

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HCC 1977-05-10

FEEDBACK EDR SYSTEM MODEL EDR-100

Applicant Bio-Feedback Systems, Inc.

K-Number K770790

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FHS 1977-05-10

DIALYZER, COIL, CD, LSA, 5M1765

Applicant Travenol Laboratories, S.A.

K-Number K770735

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BYE 1977-05-10

REGULATOR, PRESSURE, EXPIRATORY

Applicant Globe Safety Products, Inc.

K-Number K770766

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DXK 1977-05-09

ECHOCARDIOGRAPHY SYS., MODEL 3860

Applicant Honeywell, Inc.

K-Number K770756

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CBN 1977-05-09

SH-1

Applicant Delta Medical Industries

K-Number K770344

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DXK 1977-05-09

ECHOCARDIOGRAPHY SYS., MODEL 3830

Applicant Honeywell, Inc.

K-Number K770755

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DQC 1977-05-09

PULSE/PHONOCARDIOGRAPHY CHANNEL, 144

Applicant Honeywell, Inc.

K-Number K770757

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JCC 1977-05-09

SMAC SYSTEM

Applicant Mid Tech, Inc.

K-Number K770508

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FME 1977-05-06

EXAM GOWN

Applicant General Medical Co.

K-Number K770476

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DPS 1977-05-06

MONITOR, PORTABLE, PATIENT, G.E.

Applicant General Electric Co.

K-Number K770760

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GWK 1977-05-06

FIBERSCOPIC SCOPE RECORDER SYSTEM

Applicant Elmed, Inc.

K-Number K770782

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