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FDA 510(k)

SONICAID FM820, SONICAID FM830

K-Number: K002150 · 2001-03-09

ApplicantOxford Instruments
Decision Date2001-03-09
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SONICAID FM820, SONICAID FM830 is the device name listed in this FDA 510(k) record. The listed applicant is Oxford Instruments. It received FDA 510(k) clearance on 2001-03-09 under 510(k) number K002150. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONICAID FM820, SONICAID FM830?

SONICAID FM820, SONICAID FM830 is a medical device that received FDA 510(k) clearance on 2001-03-09. The listed applicant is Oxford Instruments. The 510(k) number is K002150.

When did SONICAID FM820, SONICAID FM830 receive FDA 510(k) clearance?

SONICAID FM820, SONICAID FM830 received FDA 510(k) clearance on 2001-03-09, under 510(k) number K002150.

Who is the listed applicant for SONICAID FM820, SONICAID FM830?

The FDA 510(k) record lists Oxford Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONICAID FM820, SONICAID FM830?

The FDA product code for SONICAID FM820, SONICAID FM830 is HGM.

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 Oxford Instruments 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.

K002544MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM

Related Devices (Code: HGM)

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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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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