FDA 510(k) clearance · back to tracker

ULTRASOUND IMAGING SYSTEM

Boehringer Mannheim Corp. cleared K780993 on 1978-08-10, decision: substantially equivalent

K-number

K780993

Sponsor

Boehringer Mannheim Corp.

Device

ULTRASOUND IMAGING SYSTEM

Class

Class I

Decision

Substantially Equivalent

Decision date

1978-08-10

Product code

GAD

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4800

Official FDA record

Open K780993on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.