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FDA 510(k)

SINUSON 810 ULTRASOUND SCANNER

K-Number: K827663 · 1982-08-16

ApplicantAm Labs, Inc.
Decision Date1982-08-16
Product Code
DecisionSubstantially Equivalent

Device Summary

SINUSON 810 ULTRASOUND SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Am Labs, Inc.. It received FDA 510(k) clearance on 1982-08-16 under 510(k) number K827663. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINUSON 810 ULTRASOUND SCANNER?

SINUSON 810 ULTRASOUND SCANNER is a medical device that received FDA 510(k) clearance on 1982-08-16. The listed applicant is Am Labs, Inc.. The 510(k) number is K827663.

When did SINUSON 810 ULTRASOUND SCANNER receive FDA 510(k) clearance?

SINUSON 810 ULTRASOUND SCANNER received FDA 510(k) clearance on 1982-08-16, under 510(k) number K827663.

Who is the listed applicant for SINUSON 810 ULTRASOUND SCANNER?

The FDA 510(k) record lists Am Labs, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 Am Labs, Inc. 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.

K803264SUNLAMP

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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