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FDA 510(k)

BISTAT 70/70-I ELECTROSURGICAL UNIT

K-Number: K933131 · 1994-02-15

ApplicantMedical and Scientific Enterprises, Inc.
Decision Date1994-02-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BISTAT 70/70-I ELECTROSURGICAL UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Medical and Scientific Enterprises, Inc.. It received FDA 510(k) clearance on 1994-02-15 under 510(k) number K933131. 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 BISTAT 70/70-I ELECTROSURGICAL UNIT?

BISTAT 70/70-I ELECTROSURGICAL UNIT is a medical device that received FDA 510(k) clearance on 1994-02-15. The listed applicant is Medical and Scientific Enterprises, Inc.. The 510(k) number is K933131.

When did BISTAT 70/70-I ELECTROSURGICAL UNIT receive FDA 510(k) clearance?

BISTAT 70/70-I ELECTROSURGICAL UNIT received FDA 510(k) clearance on 1994-02-15, under 510(k) number K933131.

Who is the listed applicant for BISTAT 70/70-I ELECTROSURGICAL UNIT?

The FDA 510(k) record lists Medical and Scientific Enterprises, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BISTAT 70/70-I ELECTROSURGICAL UNIT?

The FDA product code for BISTAT 70/70-I ELECTROSURGICAL UNIT is GEI.

Related Clinical Trials

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.

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Other records listing Medical and Scientific Enterprises, 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.

K913881ENDOSTAT ELECTROSURGICAL UNITK895855PHOENIXK882453POLYSCAN DIGITAL SCANNERK861233DUAL PHOTON BONE DENSITOMETER

Related Devices (Code: 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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