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FDA 510(k)

DISSECTRON PORTABLE UNIT

K-Number: K972612 · 1997-10-08

ApplicantSatelec
Decision Date1997-10-08
Product CodeLBK
DecisionSubstantially Equivalent

Device Summary

DISSECTRON PORTABLE UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Satelec. It received FDA 510(k) clearance on 1997-10-08 under 510(k) number K972612. The device is classified under product code LBK. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISSECTRON PORTABLE UNIT?

DISSECTRON PORTABLE UNIT is a medical device that received FDA 510(k) clearance on 1997-10-08. The listed applicant is Satelec. The 510(k) number is K972612.

When did DISSECTRON PORTABLE UNIT receive FDA 510(k) clearance?

DISSECTRON PORTABLE UNIT received FDA 510(k) clearance on 1997-10-08, under 510(k) number K972612.

Who is the listed applicant for DISSECTRON PORTABLE UNIT?

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

What is the FDA product code for DISSECTRON PORTABLE UNIT?

The FDA product code for DISSECTRON PORTABLE UNIT is LBK.

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Other records listing Satelec as applicant

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Related Devices (Code: LBK)

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.

K962952OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU)Olympus Optical, Co.K884412CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA.Valleylab, Inc.K884413CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATORValleylab, Inc.K883522AMERIMED ULTRASONIC SURGICAL ASPIRATION KITAmerimed US Corp.K855138BOVIE ULTRASONIC SURGICAL SYSTEMClinical Technology Corp.K853143COOPER LASER SONICS CUSA MODEL 200Cooper Lasersonics, 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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