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FDA 510(k)

ORBIOGRAPH

K-Number: K781543 · 1978-10-24

ApplicantSonometrics Systems, Inc.
Decision Date1978-10-24
Product CodeHLT
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ORBIOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Sonometrics Systems, Inc.. It received FDA 510(k) clearance on 1978-10-24 under 510(k) number K781543. The device is classified under product code HLT. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORBIOGRAPH?

ORBIOGRAPH is a medical device that received FDA 510(k) clearance on 1978-10-24. The listed applicant is Sonometrics Systems, Inc.. The 510(k) number is K781543.

When did ORBIOGRAPH receive FDA 510(k) clearance?

ORBIOGRAPH received FDA 510(k) clearance on 1978-10-24, under 510(k) number K781543.

Who is the listed applicant for ORBIOGRAPH?

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

What is the FDA product code for ORBIOGRAPH?

The FDA product code for ORBIOGRAPH is HLT.

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 Sonometrics Systems, 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.

K820751GLAUKONK812015GLAUKONK802341DIOSCAN

Related Devices (Code: HLT)

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.

K924277DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDINGChalgren Enterprises, Inc.K921815TOMEY PE-300 PORTABLE ERGTomey Corporation USAK841293PANORAMIC LOUPES - VARIOUSKeller Instruments, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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