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FDA 510(k)

ORION PLATINUM

K-Number: K003367 · 2001-01-04

ApplicantSrs Medical Systems, Inc.
Decision Date2001-01-04
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ORION PLATINUM is the device name listed in this FDA 510(k) record. The listed applicant is Srs Medical Systems, Inc.. It received FDA 510(k) clearance on 2001-01-04 under 510(k) number K003367. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORION PLATINUM?

ORION PLATINUM is a medical device that received FDA 510(k) clearance on 2001-01-04. The listed applicant is Srs Medical Systems, Inc.. The 510(k) number is K003367.

When did ORION PLATINUM receive FDA 510(k) clearance?

ORION PLATINUM received FDA 510(k) clearance on 2001-01-04, under 510(k) number K003367.

Who is the listed applicant for ORION PLATINUM?

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

What is the FDA product code for ORION PLATINUM?

The FDA product code for ORION PLATINUM is HCC.

Related Clinical Trials

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Other records listing Srs Medical 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.

K003127REGAIN DESKTOPK002834SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR

Related Devices (Code: HCC)

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.

K233580A Breathing System (ABS)Deepwell Dtx, Inc.K222101PrismGraymatters Health , Ltd.K180173FreespiraPalo Alto Health Sciences, Inc.K163448GrindCare SystemSunstar Suisse S.A.K131586CANARY BREATHING SYSTEMPalo Alto Health Sciences, Inc.K122879EEGER4 MODEL 4.3Eeg Software, LLC

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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