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FDA 510(k)

SONICAID SYSTEM 8002

K-Number: K992607 · 2001-04-27

ApplicantOxford Instruments Medical Systems
Decision Date2001-04-27
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SONICAID SYSTEM 8002 is the device name listed in this FDA 510(k) record. The listed applicant is Oxford Instruments Medical Systems. It received FDA 510(k) clearance on 2001-04-27 under 510(k) number K992607. 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 SYSTEM 8002?

SONICAID SYSTEM 8002 is a medical device that received FDA 510(k) clearance on 2001-04-27. The listed applicant is Oxford Instruments Medical Systems. The 510(k) number is K992607.

When did SONICAID SYSTEM 8002 receive FDA 510(k) clearance?

SONICAID SYSTEM 8002 received FDA 510(k) clearance on 2001-04-27, under 510(k) number K992607.

Who is the listed applicant for SONICAID SYSTEM 8002?

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

What is the FDA product code for SONICAID SYSTEM 8002?

The FDA product code for SONICAID SYSTEM 8002 is HGM.

Related Clinical Trials

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Other records listing Oxford Instruments Medical Systems 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.

K984052SYNERGY IOM SYSTEMK970902MEDILOG FD4K961638MEDILOG MPA-SK943862SONICAID MODEL MR-63 AMBULATORY ECG RECORDER

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.

K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc.K253021ANNE MaternalSibel Health, Inc.K250777Sonicaid Team3Huntleigh Healthcare , Ltd.K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.K241368Sonicaid Team3Huntleigh Healthcare , Ltd.K241009PeriCALM Patterns 3.0Perigen, Inc.

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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