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FDA 510(k)

ELECTROSURGICAL UNIT-MF 380 #60-1700

K-Number: K831291 · 1983-06-02

ApplicantAspen Laboratories, Inc.
Decision Date1983-06-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELECTROSURGICAL UNIT-MF 380 #60-1700 is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Laboratories, Inc.. It received FDA 510(k) clearance on 1983-06-02 under 510(k) number K831291. 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 ELECTROSURGICAL UNIT-MF 380 #60-1700?

ELECTROSURGICAL UNIT-MF 380 #60-1700 is a medical device that received FDA 510(k) clearance on 1983-06-02. The listed applicant is Aspen Laboratories, Inc.. The 510(k) number is K831291.

When did ELECTROSURGICAL UNIT-MF 380 #60-1700 receive FDA 510(k) clearance?

ELECTROSURGICAL UNIT-MF 380 #60-1700 received FDA 510(k) clearance on 1983-06-02, under 510(k) number K831291.

Who is the listed applicant for ELECTROSURGICAL UNIT-MF 380 #60-1700?

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

What is the FDA product code for ELECTROSURGICAL UNIT-MF 380 #60-1700?

The FDA product code for ELECTROSURGICAL UNIT-MF 380 #60-1700 is GEI.

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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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