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FDA 510(k)

CYBERJET LOCAL ANESTHESIA SYSTEM

K-Number: K964802 · 1997-05-27

ApplicantIntra Vantage, Inc.
Decision Date1997-05-27
Product CodeEGM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CYBERJET LOCAL ANESTHESIA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Intra Vantage, Inc.. It received FDA 510(k) clearance on 1997-05-27 under 510(k) number K964802. The device is classified under product code EGM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYBERJET LOCAL ANESTHESIA SYSTEM?

CYBERJET LOCAL ANESTHESIA SYSTEM is a medical device that received FDA 510(k) clearance on 1997-05-27. The listed applicant is Intra Vantage, Inc.. The 510(k) number is K964802.

When did CYBERJET LOCAL ANESTHESIA SYSTEM receive FDA 510(k) clearance?

CYBERJET LOCAL ANESTHESIA SYSTEM received FDA 510(k) clearance on 1997-05-27, under 510(k) number K964802.

Who is the listed applicant for CYBERJET LOCAL ANESTHESIA SYSTEM?

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

What is the FDA product code for CYBERJET LOCAL ANESTHESIA SYSTEM?

The FDA product code for CYBERJET LOCAL ANESTHESIA SYSTEM is EGM.

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Related Devices (Code: EGM)

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.

K243427QuickSleeper 5DentalhitecK083811W&H HANDPIECE ANESTO, MODEL: RA-5W&H Dentalwerk Buermoos GmbHK962017HYPODERMIC JET INJECTION APPARATUSAmerican Jet Injector Corp.K904279PAROJECT ANESTHETIC SYRINGERonvig Instruments, Ltd.K864294HENKE-JECT PRESSURE SYRINGE (MODIFICATION)Smith & Nephew, Inc.K864732GRADTECH SYRINGE SYSTEMGradtech

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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