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FDA 510(k)

OMNISOUND(TM) 3000

K-Number: K883893 · 1988-11-01

ApplicantPhysio Technology, Inc.
Decision Date1988-11-01
Product CodeIMG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

OMNISOUND(TM) 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Physio Technology, Inc.. It received FDA 510(k) clearance on 1988-11-01 under 510(k) number K883893. The device is classified under product code IMG. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNISOUND(TM) 3000?

OMNISOUND(TM) 3000 is a medical device that received FDA 510(k) clearance on 1988-11-01. The listed applicant is Physio Technology, Inc.. The 510(k) number is K883893.

When did OMNISOUND(TM) 3000 receive FDA 510(k) clearance?

OMNISOUND(TM) 3000 received FDA 510(k) clearance on 1988-11-01, under 510(k) number K883893.

Who is the listed applicant for OMNISOUND(TM) 3000?

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

What is the FDA product code for OMNISOUND(TM) 3000?

The FDA product code for OMNISOUND(TM) 3000 is IMG.

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Other records listing Physio Technology, 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.

K874076MODIFIED OMNISTIM(TM) ELECTRICAL MUSCLE STIMULATORK861039OMNIVAC (VACUUM ELECTRODE SYSTEM)K850850AUTOMOVE/OMNISTIM IV-ELECTRICAL MUSCLE STIMULATORK850851G5 APPARATUS T, K1, K3 & THE PRESIDENT MODEL'SK850849MYOMETER EMG BIOFEEDBACK DEVICEK843351OMNISTIM II COMBIN. THERAPY SYS

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Related Devices (Code: IMG)

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.

K244041Ultrasound Therapy Workstation (XMS-UET2)Xemis Medical Technology (Shenzhen) Co., Ltd.K153559OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy SystemAccelerated Care Plus (Acp)K120217SONICSTIMU COMBO THERAPEUTIC DEVICEShenzhen Dongdixin Technology Co., Ltd.K121059SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIMZimmer Medizinsystems GmbHK102524FUTURADr. Oliver Wenker, M.D., M.B.A.K111482SONICATOR PLUS 920Mettler Electronics Corp.

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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