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FDA 510(k)

EMC MODEL STATOME 200

K-Number: K952231 · 1995-11-21

ApplicantEmc Industries
Decision Date1995-11-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EMC MODEL STATOME 200 is the device name listed in this FDA 510(k) record. The listed applicant is Emc Industries. It received FDA 510(k) clearance on 1995-11-21 under 510(k) number K952231. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMC MODEL STATOME 200?

EMC MODEL STATOME 200 is a medical device that received FDA 510(k) clearance on 1995-11-21. The listed applicant is Emc Industries. The 510(k) number is K952231.

When did EMC MODEL STATOME 200 receive FDA 510(k) clearance?

EMC MODEL STATOME 200 received FDA 510(k) clearance on 1995-11-21, under 510(k) number K952231.

Who is the listed applicant for EMC MODEL STATOME 200?

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

What is the FDA product code for EMC MODEL STATOME 200?

The FDA product code for EMC MODEL STATOME 200 is GEI.

Related Clinical Trials

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Other records listing Emc Industries 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.

K941721EMC MODEL NO. 322870 ENDOSTATK911353EMC MODEL NO. STATOME 900

Related Devices (Code: GEI)

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.

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker InstrumentsK254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

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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